FDA PMA
Approved
🇺🇸 United States
PMA: P960043
·
Supplement: S021
·
Decision Mar 2, 2000
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- CLOSER SUTURE MEDIATED CLOSURE DEVICE & ACCESSORIES
- PMA Number
- P960043
- Supplement Number
- S021
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 2, 2000
- Date Received
- November 30, 1999
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Express GMP Supplement
- Expedited Review
- N
Advisory Committee Statement
Express supplement approval for an alternate sterilization facility located at Griffith Micro Science, Los Angeles, California.