Others titles
- MD Premarket Approval in the United States
- Medical Device Premarket Approval
Keywords
- Premarket Approval
- PMA Approvals
- US Premarket
- FDCA
- FDA Device
- CDRH and Applicants
- CDRH’s Post-Approval Studies
- Post-Approval Studies
- Meical Devices
- Post-Approval Device
FDA Premarket Approval Database
This dataset includes the Premarket Approval (PMA) data which is the Food and Drug Administration (FDA) process of scientific and regulatory review to assess the safety and effectiveness of Class III medical devices. These devices support human life and prevent impairment of human health. Due to the level of risk associated with Class III devices, general and special controls are insufficient to assure the safety of these devices and require a PMA application to obtain marketing clearance.
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Description
Premarket Approval (PMA) is the most stringent type of device marketing application required by Food and Drug Administration (FDA). The applicant must receive FDA approval of its PMA application under section 515 of the Food, Drug, and Cosmetic (FD&C) Act prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device. The PMA owner, however, can authorize use of its data by another.
The PMA applicant is usually the person who owns the rights, or otherwise has authorized access, to the data and other information to be submitted in support of FDA approval. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity. The applicant is often the inventor/developer and ultimately the manufacturer.
FDA regulations provide 180 days to review the PMA and make a determination. In reality, the review time is normally longer. Before approving or denying a PMA, the appropriate FDA advisory committee may review the PMA at a public meeting and provide FDA with the committee’s recommendation on whether FDA should approve the submission. After FDA notifies the applicant that the PMA has been approved or denied, a notice is published on the Internet (1) announcing the data on which the decision is based, and (2) providing interested persons an opportunity to petition FDA within 30 days for reconsideration of the decision.
About this Dataset
Data Info
Date Created | 2013 |
---|---|
Last Modified | 2024-06-15 |
Version | 2024-06-15 |
Update Frequency |
Monthly |
Temporal Coverage |
1960 to 2024-06-15 |
Spatial Coverage |
United States |
Source | John Snow Labs; Food and Drug Administration (FDA); |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
Keywords | Premarket Approval, PMA Approvals, US Premarket, FDCA, FDA Device, CDRH and Applicants, CDRH’s Post-Approval Studies, Post-Approval Studies, Meical Devices, Post-Approval Device |
Other Titles | MD Premarket Approval in the United States, Medical Device Premarket Approval |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
PMA_Number | Premarket Approval Number | string | - |
Supplement_Number | PMA Supplement Number | string | - |
Applicant | The Name of the applicant | string | - |
Address_Line_1 | The Address of the applicant | string | - |
Address_Line_2 | Second part of the Address of the applicant | string | - |
City | The City of the applicant | string | - |
State_Abbreviation | The State of the applicant | string | - |
Zip_Code | The Zip code of the applicant | string | - |
Zip_Extension | The zip code extension of the applicant | string | - |
Generic_Name | Generic Name of the product | string | - |
Trade_Name | Trade Name of the product | string | - |
Product_Code | Product Code Classification | string | - |
Advisory_Committee | Advisory Committee | string | - |
Supplement_Type | Type of Supplement | string | - |
Supplement_Reason | Primary Reason for Supplement | string | - |
Is_Review_Granted | Expedited Review Granted | string | - |
Received_Date | Date Received | date | - |
Decision_Date | PMA date decision | date | - |
Docket_Number | Docket number | string | - |
Fed_Reg_Notice_Date | Date of federal register notice | date | - |
Decision_Code | FDA decision code | string | - |
Approval_Order_Statement | FDA approval order statement | string | - |
Data Preview
PMA Number | Supplement Number | Applicant | Address Line 1 | Address Line 2 | City | State Abbreviation | Zip Code | Zip Extension | Generic Name | Trade Name | Product Code | Advisory Committee | Supplement Type | Supplement Reason | Is Review Granted | Received Date | Decision Date | Docket Number | Fed Reg Notice Date | Decision Code | Approval Order Statement |
P890055 | S029 | Intera Oncology | 180 Wells Ave, Suite 300A | Newton | MA | 02459 | Pump, infusion, implanted, programmable | MEDSTREAM PROGRAMMABLE INFUSION SYSTEM | LKK | HO | Normal 180 Day Track No User Fee | Postapproval Study Protocol - OSB | False | 2011-01-18 | 2011-03-15 | APPR | APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. | ||||
P890055 | S030 | Intera Oncology | 180 Wells Ave, Suite 300A | Newton | MA | 02459 | Pump, infusion, implanted, programmable | MEDSTREAM PROGRAMMABLE INFUSION SYSTEM | LKK | HO | Normal 180 Day Track No User Fee | Postapproval Study Protocol - OSB | False | 2011-01-18 | 2011-03-15 | APPR | APPROVAL OF THE POST-APPROVAL PROTOCOL. | ||||
P890055 | S031 | Intera Oncology | 180 Wells Ave, Suite 300A | Newton | MA | 02459 | Pump, infusion, implanted, programmable | MEDSTREAM PROGRAMMABLE INFUSION SYSTEM | LKK | HO | Normal 180 Day Track | Change Design/Components/Specifications/Material | False | 2011-01-18 | 2013-02-12 | APPR | APPROVAL FOR MODIFICATIONS TO THE MEDSTREAM REFILL KIT AND O.R. PREP KIT. THE PMA SUPPLEMENT ALSO REQUESTED APPROVAL FOR STERILIZATION TO OCCUR AT STERIS ISOMEDIX SERVICES IN NORTHBOROUGH, MASSACHUSETTS AND KIT PACKAGING TO OCCUR AT CONTECH MEDICAL, INC., IN PROVIDENCE, RHODE ISLAND. | ||||
P980037 | S034 | Boston Scientific Corp. | One Scimed Place | Maple Grove | MN | 55311 | 1566.0 | CATHETER, CORONARY, ATHERECTOMY | ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM | MCX | CV | Real-Time Process | Change Design/Components/Specifications/Material | False | 2011-01-18 | 2011-03-17 | APPR | APPROVAL FOR CHANGES TO THE ANGIOJET ULTRA CONSOLE SOFTWARE. | |||
P070009 | S011 | OBTECH MEDICAL GMBH | LANDIS AND GYR STRASSE 1 | ZUG | CH-63 | 6300.0 | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY | REALIZE ADJUSTABLE GASTRIC BAND | LTI | GU | Normal 180 Day Track | Change Design/Components/Specifications/Material | False | 2011-01-18 | 2011-07-15 | APPR | APPROVAL FOR THE REALIZE PRESSURE RECORDING SYSTEM, INDICATED TO RECORD AND DISPLAY FLUID PRESSURE VARIATIONS WITHIN A CLOSED SYSTEM BY CONVERTING MECHANICAL INPUTS TO ANALOG/DIGITAL ELECTRICAL SIGNALS. | ||||
P850007 | S031 | Orthofix, Inc. | 3451 Plano Parkway | Lewisville | TX | 75056 | Stimulator, bone growth, non-invasive | SPINAL-STIM SPINAL FUSION SYSTEM | LOF | OR | Real-Time Process | Change Design/Components/Specifications/Material | False | 2011-01-19 | 2011-03-11 | APPR | APPROVAL FOR DESIGN MODIFICATIONS TO THE GARMENT COVERING, THE TREATMENT COILS, LIQUID CRYSTAL DISPLAY, CONTROL UNIT HOUSING PROFILE, ORIENTATION OF THE CONTROLS, SOFTWARE/ FIRMWARE, POWER SUPPLY CORD, AND LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SPINAL-STIM AND IS INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS AND AS A NON-OPERATIVE TREATMENT FOR SALVAGE OF FAILED SPINAL FUSION, WHERE A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE THE LAST SURGERY. | ||||
P030034 | S005 | Orthofix, Inc. | 3451 Plano Parkway | Lewisville | TX | 75056 | Stimulator, bone growth, non-invasive | CERVICAL-STIM CERVICAL FUSION SYSTEM | LOF | OR | Real-Time Process | Change Design/Components/Specifications/Material | False | 2011-01-19 | 2011-03-11 | APPR | APPROVAL FOR DESIGN MODIFICATIONS TO THE GARMENT COVERING, THE TREATMENT COILS, LIQUID CRYSTAL DISPLAY, CONTROL UNIT HOUSING PROFILE, ORIENTATION OF THE CONTROLS, SOFTWARE/ FIRMWARE, POWER SUPPLY CORD, AND LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CERVICAL-STIM AND IS INDICATED AS AN ADJUNCT TO CERVICAL FUSION SURGERY IN PATIENTS AT HIGH RISK FOR NON-FUSHION. | ||||
P990074 | S023 | Allergan | 2525 DUPONT DR. | IRVINE | CA | 92612 | Prosthesis, breast, inflatable, internal, saline | NATRELLE SALINE-FILLED BREAST IMPLANTS | FWM | SU | Normal 180 Day Track No User Fee | Labeling Change - Indications/instructions/shelf life/tradename | False | 2011-01-24 | 2013-09-10 | APPR | APPROVAL FOR PHYSICIAN AND PATIENT LABELING REVISIONS TO INCLUDE INFORMATION ABOUT ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) AND CONNECTIVE TISSUE DISEASE (CTD) RISKS WITH THE NATRELLE SALINE-FILLED BREAST IMPLANT. | ||||
P010031 | S232 | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT | 8200 CORAL SEA STREET N.E. | MOUNDS VIEW | MN | 55112 | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT | NIK | CV | Panel Track | Labeling Change - Indications/instructions/shelf life/tradename | False | 2011-01-24 | 2012-04-04 | 12M-0814 | 2012-07-31 | APPR | APPROVAL FOR A MODIFICATION TO THE INDICATIONS FOR USE AS FOLLOWS.FOR THE CONCERTO CRT-D MODEL C154DWK, CONSULTA CRT-D MODEL D224TRK, CONCERTO II CRT-D MODEL D274TRK, PROTECTA CRT-D MODEL D334TRG, PROTECTA CRT-D MODEL D334TRM, PROTECTA XT CRT-D MODEL D314TRG, PROTECTA XT CRT-D MODEL D314TRM, AND CONSULTA CRT-D MODEL D204TRM CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) THE INDICATIONS FOR USE ARE: THE CRT-D SYSTEM IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIASAND FOR PROVIDING CARDIAC RESYNCHRONIZATION THERAPY IN HEART FAILURE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE OPTIMAL MEDICAL THERAPY, AND MEET ANY OF THE FOLLOWING CLASSIFICATIONS: 1) NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASS III OR IV AND WHO HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A PROLONGED QRS DURATION. 2) LEFT BUNDLE BRANCH BLOCK (LBBB) WITH A QRS DURATION >= 130 MS, LEFT VENTRICULAR EJECTIONFRACTION <= 30%, AND NYHA FUNCTIONAL CLASS II. THE SYSTEM IS ALSO INDICATED FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK FOR DEVELOPING ATRIAL TACHYARRHYTHMIAS. ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP), AND POST MODE SWITCH OVERDRIVE (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND AN ICD INDICATION. FOR THE MAXIMO II CRT-D MODEL D284TRK AND MAXIMO IICRT-D MODEL D264TRM CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) THE INDICATIONS FOR USE ARE: (FOR ADDITIONAL INFORMATION, PLEASE SEE APPROVAL ORDER.) | ||
P910077 | S110 | BOSTON SCIENTIFIC | 4100 Hamline Avenue North | St. Paul | MN | 55112 | Implantable cardioverter defibrillator (non-CRT) | LATITUDE PATIENT MANAGEMENT SYSTEM | LWS | CV | Real-Time Process | Change Design/Components/Specifications/Material | False | 2011-01-24 | 2011-03-03 | APPR | APPROVAL FOR MODIFICATION TO THE LATITUDE PATIENT MANAGEMENT SYSTEM REGULATED APPLICATION SOFTWARE V7.0.02 ON LATITUDE SYSTEM SERVER (MODEL 6488) AND RELATED COMMUNICATOR SOFTWARE CHANGES (MODEL 6476). |