Medical Devices
File Description for the CDRH Releasable (Approved) PMAs
Each data element is separated by a | pipe symbol. The position of the element represents where it appears in the piped line, IE,
position1|position2|position3|position4|etc.
(Previous releases of this data were in fixed width format with an X at the end; this is no longer the case.)
| Position | Description |
|---|---|
| 1 | PMA Number |
| 2 | Supplement Number |
| 3 | Applicant |
| 4 | Generic Name |
| 5 | Trade Name |
| 6 | Product Code |
| 7 | Advisory Committee |
| 8 | Type of Supplement |
| 9 | Primary Reason for Supplement |
| 10 | Expedited Review Granted (Y/N) |
| 11 | Date Received (mm-dd-yyyy) |
| 12 | Date Decision (mm-dd-yyyy) |
| 13 | Docket Number |
| 14 | Date of Federal Register Notice (mm-dd-yyyy) |
| 15 | Decision Code |
| 16 | Approval Order Statement |
THIRTY DAY TRACK
PANEL TRACK
SPECIAL(IMMEDIATE TRACK)
REAL-TIME PROCESS
30-DAY NOTIFICATION
135 REVIEW TRACK FOR 30-DAY NOTIFICATION
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COLOR ADDITIVE
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE
CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SPECIFICATIONS
CHANGE IN LOCATION PILOT
DESIGN CHANGE - MINOR
LABELING CHANGE - INDICATIONS
LABELING CHANGE - INSTRUCTIONS
LABELING CHANGE - MINOR
LABELING CHANGE - OTHER
LABELING CHANGE - PERFORMANCE CHARACTERISTICS
LABELING CHANGE - SHELF-LIFE
LABELING CHANGE - TRADE NAME
LOCATION CHANGE - OTHER
LOCATION CHANGE: DISTRIBUTOR
LOCATION CHANGE: MANUFACTURER
LOCATION CHANGE: PACKAGER
LOCATION CHANGE: STERILIZER
POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL
PROCESS CHANGE - OTHER
PROCESS CHANGE: MANUFACTURING
PROCESS CHANGE: PACKAGING
PROCESS CHANGE: STERILIZATION
OTHER