FDA Device Pre-market Approval (PMA) Database






Update Frequency

Table Information

Pre-market Approval
Medical Device
Class III devices
Device PMAs

FDA Device Pre-market Approval (PMA) Database

Table Description


PMA is any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference. “PMA” includes a new drug application for a device under section 520(l) of the FD&C Act.

The database contains details about specific products and the sponsors of premarket approval applications and supplements. It also contains administrative and tracking information about the applications and receipt and decision dates. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. An approved PMA Application is, in effect, a private license granted to the applicant for marketing a particular medical device.

Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or that present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices.

Data Source

U.S. Food and Drug Administration (fda)

Data Coverage

  • Time period: 1976 to present

Update Frequency

  • This dataset is updated every month.

Data Fields


This equates to the review division within CDRH in which the PMA would be reviewed, if it were reviewed today; this is derived from the procode and is always same as the “Review Panel” field in the Device Classification database (e.g. GU).

Value is one of the following

  • AN = Anesthesiology
  • CV = Cardiovascular
  • CH = Clinical Chemistry
  • DE = Dental
  • EN = Ear, Nose, Throat
  • GU = Gastroenterology, Urology
  • HO = General Hospital
  • HE = Hematology
  • IM = Immunology
  • MI = Microbiology
  • NE = Neurology
  • OB = Obstetrics/Gynecology
  • OP = Ophthalmic
  • OR = Orthopedic
  • PA = Pathology
  • PM = Physical Medicine
  • RA = Radiology
  • SU = General, Plastic Surgery
  • TX = Clinical Toxicology


Full spelling of the Advisory committee abbreviation (e.g. gastroenterology).


Approval order statement: a brief description of the reason for the supplement/application approval by FDA.


Common or generic name as specified in the submission. Not to be confused with the official device nomenclature name related to the product code.


FDA assigned supplement number.


General description for the reason for the supplement or application.


Link to general criteria used for PMA regulation (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=814). The “PMA regulation” (21 CFR Part 814) sets forth general criteria for determining when you must submit a PMA supplement or a 30-day notice for a device modification or manufacturing change (21 CFR 814.39).


This is the proprietary name of the approved device.



Documentation forthcoming.


Date that the FDA Document Control Center received the submission.


A four digit code reflecting the final decision for a PMA submission.

Value is one of the following

APPR = Approval: PMA has been approved.

WTDR = Withdrawal: PMA has been withdrawn.

DENY = Denial: PMA has been denied.

LE30 = 30 day notice acceptance (decision made in ≤30 days).

APRL = Reclassification after approval.

APWD = Withdrawal after approval.

GT30 = No decision made in 30 days.

APCV = Conversion after approval.


A three-letter identifier assigned to a device category. Assignment is based upon the medical device classification designated under 21 CFR Parts 862-892, and the technology and intended use of the device. Occasionally these codes are changed over time.


FDA-assigned premarket application number, including leading letters. Leading letter “D” indicates Product Development Protocol type of Premarket Approval. Leading letters “BP” indicates Premarket Approval by Center for Biologics Evaluation and Research. Leading letter “H” indicates Humanitarian Device Exemption approval. Leading letter “N” indicates New Drug Application. Early PMAs were approved as NDAs. Leading letter “P” indicates Premarket Approval.


The assigned posted docket number in the Federal Register.


Flag indicating that the approval review process was expedited.

Value is one of the following

Y = Yes

N = No


The manufacturer of record or third party who submits a PMA submission for clearance (also known as sponsor).

This is an .exact field. It has been indexed both as its exact string content, and also tokenized.


A risk based classification system for all medical devices ((Federal Food, Drug, and Cosmetic Act, section 513)

Value is one of the following

1 = Class I (low to moderate risk): general controls

2 = Class II (moderate to high risk): general controls and special controls

3 = Class III (high risk): general controls and Premarket Approval (PMA)

U = Unclassified

N = Not classified


device name

This is the proprietary name, or trade name, of the cleared device.


Facility identifier assigned to facility by the FDA Office of Regulatory Affairs.


Regulation Medical Specialty is assigned based on the regulation (e.g. 21 CFR Part 888 is Orthopedic Devices) which is why Class 3 devices lack the “Regulation Medical Specialty” field.


The classification regulation in the Code of Federal Regulations (CFR) under which the device is identified, described, and formally classified (Code of Federal regulations Title 21, 862.00 through 892.00). The classification regulation covers various aspects of design, clinical evaluation, manufacturing, packaging, labeling, and postmarket surveillance of the specific medical device.