DERMAGRAFT-TC(TM)
FDA premarket approval P960007/S004 · decided 1998-05-12
Approval details
- PMA number
- P960007
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DERMAGRAFT-TC(TM)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 1997-10-21
- Decision date
- 1998-05-12
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for the new product label and directions for use for the new indication of partial thickness burns that are mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.