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| File Description for the CDRH Releasable (Approved) PMAs |  |
| Position | Description |
|---|---|
| 1 | PMA Number |
| 8 | Supplement Number |
| 12 | Applicant |
| 62 | Generic Name |
| 182 | Trade Name |
| 302 | Product Code |
| 305 | Advisory Committee |
| 307 | Type of Supplement |
| 357 | Primary Reason for Supplement |
| 477 | Expedited Review Granted (Y/N) |
| 478 | Date Received (dd-Mon-yyyy) |
| 489 | Date Decision (dd-Mon-yyyy) |
| 500 | Docket Number |
| 508 | Date of Federal Register Notice (dd-Mon-yyyy) |
| 519 | Decision Code |
| 523 | Approval Order Statement |
| 2523 | 'X' - End of Record |
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
(Updated August 20, 2002)
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