FDA PMA
Approved
🇺🇸 United States
PMA: P990004
·
Supplement: S001
·
Decision Dec 2, 1999
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- SURGIFOAM ABSORBABLE GELATIN SPONGE, USP
- PMA Number
- P990004
- Supplement Number
- S001
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 2, 1999
- Date Received
- November 15, 1999
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the addition of sponges 3mm and 7mm thick.