TRANSCYTE(TM)
FDA premarket approval P960007/S014 · decided 2000-05-19
Approval details
- PMA number
- P960007
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRANSCYTE(TM)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 2000-03-01
- Decision date
- 2000-05-19
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL TO CONDUCT THE FINAL PRODUCT STERILITY TEST IN-HOUSE UNDER THE CONDITIONS OF AN ISOLATOR ENVIRONMENT.
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