TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
FDA premarket approval P960007/S021 · decided 2011-09-20
Approval details
- PMA number
- P960007
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
- Generic name
- Dressing, wound and burn, interactive
- Applicant
- Shire Regenerative Medicine
- Date received
- 2011-03-07
- Decision date
- 2011-09-20
- Days to decision
- 197 days
- Decision code
- APPR
- Product code
- MGR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- San Diego, CA
- Statement
- APPROVAL FOR CHANGING FROM THE USE OF FETAL BOVINE SERUM TO THE USE OF BOVINE CALF SERUM AS A MEDIA SUPPLEMENT FOR EXPANDING CELLS IN EXPANDED SURFACE ROLLER BOTTLES, I.E., THE CELL EXPANSION PROCESS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.