Pma fda database

Pma fda database. A supplement may have changed the device description/function or indication from Post-Approval Studies (PAS) Database; Obtaining PMA Approval Letters, PAS Protocols, or PAS Final Reports U. Dec 6, 2023 · U. Search the Registration & Listing database ; Establishment Registration and Medical Device Listing Files for Download ; Releasable establishment registration and listing information under the Device: Cross-Seal Suture-Mediated Vascular Closure Device System: Generic Name: Device, hemostasis, vascular: Applicant: Bolton Medical, Inc. 1-888-INFO-FDA (1 Databases - 1 to 10 of 500 Results * 1 2 PMA Number. 5310 The FDA uploads these into the MAUDE database and includes an additional statement in the narrative stating, "This report reflects information received by FDA in the form of a notification per 803 Aug 26, 2024 · Databases - 510(k) | DeNovo | This medical device record is a PMA supplement. 37) or supplements (§814. If you cannot locate the PMA data you desire in DRS or have other questions about a Parts Manufacturer Approval, contact the FAA Certificate Management Branch in the geographical area of the PMA The complete FDA Premarket Approval Application (PMA) database is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use. It includes information about Device Classification Product Codes, Premarket Approvals (PMA), Premarket Notifications (510[K]), MAUDE Medical Device Adverse Event Reports, and CDRH Medical Device Recalls. Search the database by: PMA summary of safety and effectiveness. 1-888-INFO-FDA (1 Food and Drug Administration 10903 New Hampshire Ave. 2023 Monthly PMA Listings. , safety and effectiveness, data analysis, and bioresearch monitoring. 1-888-INFO-FDA (1 Dec 6, 2023 · A premarket approval application (PMA) or an investigational device exemption application (IDE) usually contains data and other information that the applicant has developed and regards as trade 3 days ago · Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. 1678: Applicant: DIASORIN, INC. The review of a premarket approval application (PMA) is a four 3 days ago · Databases - 510(k) | DeNovo | This medical device record is a PMA supplement. Aug 19, 2024 · Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. The FDA 510k submission and the FDA PMA (Premarket Approval) are two distinct processes for gaining FDA approval for medical devices, each with its own requirements and procedures. 1-888-INFO-FDA (1 Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. Let's quickly break it down: FDA 510(k) Submission (Premarket Notification) Databases - 510(k) | DeNovo | This medical device record is a PMA supplement. go to link nearby for FDA’s In Vitro Diagnostic Product Database enter a search term (for example the type of test, name, company, or other key word) in the blank space click on “Search” 3 days ago · Databases As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes. 1-888-INFO-FDA (1 Aug 26, 2024 · Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. 0 mm. 1-888-INFO-FDA (1 If the PMA has been approved, the new owner need only report that the transfer of PMA ownership will not result in a change or modification that would require a submission of a PMA supplement Aug 26, 2024 · The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. U. 1-888-INFO-FDA (1 Amendments (§ 814. Devices Approved in 2022 (archived) Search the Premarket Approval (PMA Aug 26, 2024 · Patients who are negative for the mutations listed in Table 1 should be reflexed to routine biopsy and their tumor mutation status confirmed using an FDA-approved tumor tissue test, if feasible. Silver Spring, MD 20993-0002 Jul 17, 2024 · FDA 510k vs. , a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510 3 days ago · Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. A supplement may have changed the device description/function or indication from Aug 26, 2024 · Databases - 510(k) | DeNovo | This medical device record is a PMA supplement. Food and Drug Administration Search Menu; prior to January 31, 2000 or by the FDA since that date. 1-888-INFO-FDA (1 Sep 11, 2020 · Cross-checked and validated medical devices and algorithms. CDRH Standards Database. 1-888-INFO-FDA (1 Aug 26, 2024 · List of somatic variants for therapeutic useIndication Gene Variant Targeted therapyColorectal Cancer (CRC) KRAS KRAS wild-type (absence of mutations in codons 12 and 13) ERBITUX® (cetuximab), orVECTIBIX® (panitumumab)Non-Small Cell Lung Cancer(NSCLC) EGFR Exon 19 Deletions and Exon 21 L858R Substitution Mutations EGFR Tyrosine Kinase Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. Suite 260 Irving, TX 75038 3 days ago · Approval for the BioFreedom Drug Coated Stent System. Food and Drug Administration. A supplement may have changed the device description/function or indication from Nov 6, 2023 · Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. Genomic findings other than those listed in Table 1 of the intended use statement are not prescriptive or conclusive for labeled use of any specific Oct 5, 2023 · In DRS you may search PMAs by PMA holder, PMA article name, number, approval basis, as well as make and model on which the PMA part can be installed. A supplement may have changed the device description/function or indication from Aug 26, 2024 · Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. S. 1-888-INFO-FDA (1 May 11, 2016 · Databases - 510(k) | DeNovo | This medical device record is a PMA supplement. Submissions, the information may also be used for PMA submissions. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk Aug 26, 2024 · Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA 3 days ago · A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. 1-888-INFO-FDA (1 Aug 26, 2024 · Drug-eluting percutaneous transluminal coronary angioplasty catheter: Applicant: Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311-1566: PMA Number: P230035: Date Received: 10/05/2023: Decision Date: 02/29/2024: Product Code: OOB : Docket Number: 24M-1081: Notice Date: 03/08/2024: Advisory Committee: Cardiovascular: Clinical Aug 26, 2024 · Databases - 510(k) | DeNovo | This medical device record is a PMA supplement. Additional topics include: approved Jul 6, 2023 · Manufacturer Device Name Approval Date Premarket Database; Avive Solutions, Inc. Food and Drug Administration 10903 New Hampshire Ave Silver Spring, MD 20993. In a Modular PMA the complete contents of a PMA are broken down into well-delineated components (or module) and each component is submitted to FDA as soon as the applicant has 3 days ago · Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. A supplement may have changed the device description/function or indication from Oct 5, 2023 · For access to the approval packages for PMA originals and panel-track supplements, please refer to the online PMA database. The labeling included below is the version at time of approval of the original PMA or panel track supplement Post-Approval Studies (PAS) Database. A supplement may have changed the device description/function or indication from Aug 19, 2024 · LUTONIX DRUG COATED BALLOON PTA CATETER: Generic Name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter: Applicant: LUTONIX 9409 SCIENCE CENTER DR NEW HOPE, MN 55428: PMA Number: P130024: Date Received: 11/25/2013: Decision Date: 10/09/2014: Product Code: ONU : Docket Number: 14M-1597: Notice Date: 10/14/2014: Advisory Committee Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. A search query will produce information from the database in the following format: U. > 98% of all Premarket Approval Application records are all plain, ASCII characters. 1-888-INFO-FDA (1 3 days ago · Device: Shield: Generic Name: System, colorectal neoplasia, DNA methylation and hemoglobin detection: Applicant: Guardant Health, Inc. 39) are submitted to FDA for changes or revisions to the original PMA submission. Aug 26, 2024 · Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. Device FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, Aug 12, 2024 · Databases Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. gov (800) 638-2041 3 days ago · Databases - 510(k) | DeNovo | This medical device record is a PMA supplement. 1-888-INFO-FDA (1 Aug 26, 2024 · Databases - 510(k) | DeNovo | This medical device record is a PMA supplement. Food and Drug Administration Search Menu; Search FDA Submit search. , WO32-5295 (PMA) and HDE devices. 3 days ago · Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or 3 days ago · Device: Duo Venous Stent System: Generic Name: Stent, iliac vein: Applicant: Vesper Medical, Inc. gov Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Nov 6, 2023 · An approved Premarket Approval Application (PMA) -- like an approved New Drug Application (NDA) -- is, in effect, a private license granted to the applicant for marketing a particular See full list on fda. Avive Automated External Defibrillator (AED) System: 10/31/2022: P210015 Jul 19, 2023 · The FDA PMA database is a good starting point as you prepare for your PMA approval prep work. January 2023 PMA Approval Listing; February You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. Food and Drug Administration 10903 New Hampshire The following list of Federal Register notices site the original publication of the PMA regulation and subsequent changes to the regulation. Dec 5, 2012 · Be sure to look at the supplements to get an up-to-date information on device changes. 1990 INDUSTRIAL BLVD. 0 mm and total lesion lengths Aug 26, 2024 · Device: Xstim Spine Fusion Stimulator: Generic Name: Stimulator, bone growth, non-invasive: Applicant: Xstim Inc 1231 Greenway Drive. 1-888-INFO-FDA (1 Device: PRO-TRAC II TACROLIMUS ELISA KIT: Generic Name: ENZYME IMMUNOASSAY, TRACROLIMUS: Regulation Number: 862. A supplement may have changed the device description/function or indication from Aug 26, 2024 · Device: Cardinal Health Multifunctional Defibrillation Electrode: Generic Name: Automated external defibrillators (non-wearable) Regulation Number: 870. The sections of 21 CFR 814 affected by the Federal Aug 26, 2024 · Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. 1-888-INFO-FDA (1 CDER highlights key Web sites. A supplement may have changed the device description/function or indication from A Class III device that fails to meet PMA requirements is considered adulterated under section 501(f) of the FD&C Act and may not be marketed. 3 days ago · Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. Decision Date. This device is indicated for improving coronary luminal diameter in patients at high risk for bleeding with symptomatic ischemic heart disease due to de novo lesions of length = 32 mm in native coronary arteries with a reference diameter ranging between 2. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk Overview of PMA clinical studies information including: IDE, research conducted outside the U. Food and Drug Administration 10903 New Hampshire Ave. 1-888-INFO-FDA (1 Aug 26, 2024 · Drug coated prostatic dilation catheter for benign prostatic hyperplasia: Applicant: Urotronic, Inc 2495 Xenium Lane Minneapolis, MN 55449: PMA Number: P220029: Date Received: 12/12/2022: Decision Date: 06/30/2023: Product Code: QXB : Docket Number: 23M-2744: Notice Date: 07/07/2023: Advisory Committee: Gastroenterology/Urology: Clinical Trials Aug 26, 2024 · Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. 1-888-INFO-FDA (1 Oct 3, 2022 · Introduction. FDA PMA: A Brief Breakdown. Cross-checking and validation of all announcements resulted in a database with 64 AI/ML based, FDA-approved medical devices and algorithms. 25 mm and 4. How Do I . All Medical Device Databases. 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. 1-888-INFO-FDA (1 Alphabetical Listing of PMA Guidance Documents. 1-888-INFO-FDA (1 Aug 19, 2024 · Device: AAV5 DetectCDx: Generic Name: Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors: Applicant: ARUP Laboratories 3 days ago · Databases - 510(k) | DeNovo | This medical device record is a PMA supplement. gov is a database of publicly and privately supported clinical studies of human Dec 21, 2023 · A companion diagnostic device can be in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. 1-888-INFO-FDA (1 On this page: Overview; Steps in the PMA Process; Early Collaboration & Day-100 Meetings; FDA Action on a PMA; References; Overview. The device is indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD) ranging from 4. A supplement may have changed the device description/function or indication from 3 days ago · this database includes: Premarket and Postmarket data about medical devices. 1-888-INFO-FDA (1 Aug 26, 2024 · Approval for the ELUVIA Drug-Eluting Vascular Stent System. Although a PMA supplement applies to an approved PMA, in many cases Nov 6, 2023 · For access to the approval packages for PMA originals and panel-track supplements, please refer to the online PMA database. Aug 26, 2024 · Databases Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. A supplement may have changed the device description/function or indication from . hhs. Links to all available summary review memos can be found here. 1-888-INFO-FDA (1 3 days ago · Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. DICE@fda. Featured. 1-888-INFO-FDA (1 Search the 510(k) Database; Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. Visit it to check out approved devices, connected data, attached documents from the submission process, and more. ClinicalTrials. A supplement may have changed the device description/function or indication from Premarket Approvals (PMA) Database. The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), Apr 22, 2024 · The completion of this Premarket Submission Coversheet (Form FDA 3514) is voluntary and will not affect any Food and Drug Administration (FDA) decision concerning your submission, but will help 3 days ago · Databases Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. 3000 Hanover Street Aug 26, 2024 · Databases - 510(k) | DeNovo | The labeling included below is the version at time of approval of the original PMA or panel track MD 20993 Ph. 1285 Drummers Lane Suite 105 Wayne, PA 19087: PMA Number: P230021 Modular PMA. 0 - 6. Each person who wants to market in the U. (dba Terumo Aortic) Aug 26, 2024 · Databases - 510(k) | DeNovo | This medical device record is a PMA supplement. oqo jddw tcudl gpekuo iutie pxwg gmwvjotr whw oqctqnf doukye