DERMAGRAFT-TC(TM)
FDA premarket approval P960007/S002 · decided 1998-05-29
Approval details
- PMA number
- P960007
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Postapproval Study Protocol
- Trade name
- DERMAGRAFT-TC(TM)
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 1997-05-05
- Decision date
- 1998-05-29
- Days to decision
- 389 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 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 sucha covering prior to autograft placement.
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