FDA PMA
Approved
🇺🇸 United States
PMA: P990004
·
Supplement: S002
·
Decision Feb 8, 2000
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- SURGIFORM ABSORBABLE GELATION SPONGE, USP
- PMA Number
- P990004
- Supplement Number
- S002
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 8, 2000
- Date Received
- November 16, 1999
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
A change in the "Indications for Use" statement.