TRANSCYTE
FDA premarket approval P960007/S011 · decided 1999-11-26
Approval details
- PMA number
- P960007
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRANSCYTE
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 1999-08-19
- Decision date
- 1999-11-26
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for changing the frequency of the in-process sterility testing conducted on the device.
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