DERMAGRAFT-TC(TM)
FDA premarket approval P960007/S007 · decided 1998-05-29
Approval details
- PMA number
- P960007
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- DERMAGRAFT-TC(TM)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 1998-01-09
- Decision date
- 1998-05-29
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for a post approval study assessing the incidence of burn wound infection in patients who require a temporary wound covering, Dermagraft-TC, for surgically excised full-thickness and deep-partial thickness thermal burn wounds in patients who require such a covering prior to autograft placement.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.