TRANSCYTE
FDA premarket approval P960007/S013 · decided 2000-03-16
Approval details
- PMA number
- P960007
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TRANSCYTE
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 1999-09-02
- Decision date
- 2000-03-16
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval to extend the expiration date to 20 months and to revise product labeling to indicate that the device may be stored by the end user at temperatures between -70C and -20C.
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