TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
FDA premarket approval P960007 · decided 1997-03-18
Approval details
- PMA number
- P960007
- Trade name
- TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 1996-03-29
- Decision date
- 1997-03-18
- Days to decision
- 354 days
- Decision code
- APCV
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR THE DERMAGRAFT-TC(TM). THE DEVICE IS INDICATED FOR USE AS A TEMPORARY WOUND COVERING FOR SURGICALLY EXCISED FULL-THICKNESS AND DEEP PARTIAL-THICKNESS THERMAL BURN WOUNDS IN PATIENTS WHO REQUIRE SUCH A COVERING PRIOR TO AUTOGRAFT PLACEMENT
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