DERMAGRAFT
FDA premarket approval P000036 · decided 2001-09-28
Approval details
- PMA number
- P000036
- Trade name
- DERMAGRAFT
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 2000-08-25
- Decision date
- 2001-09-28
- Days to decision
- 399 days
- Decision code
- APCV
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE DERMAGRAFT(R). THE DEVICE IS INDICATED FOR USE IN THE TREATMENT OF FULL-THICKNESS DIABETIC FOOT ULCERS GREATER THAN SIX WEEKS DURATION WHICH EXTEND THROUGH THE DERMIS, BUT WITHOUT TENDON MUSCLE, JOINT CAPSULE OR BONE EXPOSURE. DERMAGRAFT(R) SHOULD BE USED IN CONJUNCTION WITH STANDARD WOUND CARE REGIMENS AND IN PATIENTS THAT HAVE ADEQUATE BLOOD SUPPLY TO THE INVOLVED FOOT.
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