DERMAGRAFT-TC(TM)
FDA premarket approval P960007/S003 · decided 1997-11-24
Approval details
- PMA number
- P960007
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- DERMAGRAFT-TC(TM)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 1997-10-22
- Decision date
- 1997-11-24
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for a change of Dermagraft-TC storage conditions to include -20C frost-free freezers.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.