TRANSCYTE
FDA premarket approval P960007/S008 · decided 1998-08-14
Approval details
- PMA number
- P960007
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TRANSCYTE
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 1998-07-10
- Decision date
- 1998-08-14
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- Approval for changing the name of the product from Dermagraft-TC to TransCyte(TM) and for minor editoral changes to the Directions for Use and product label. The device, as modified, will be marketed under the trade name TransCyte(TM) and is indicated for use as a temporary wound covering for sugically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such a covering prior to autograft placement; and for the treatment of mid-dermal to indeterminate dep
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