FDA PMA
Approved
🇺🇸 United States
PMA: P960043
·
Supplement: S024
·
Decision May 19, 2000
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- CLOSER 6 FR. SUTURE MEDIATED CLOSURE DEVICE
- PMA Number
- P960043
- Supplement Number
- S024
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 19, 2000
- Date Received
- April 4, 2000
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MODIFICATION TO THE MARKER TUBE OF THE CLOSER(TM) SMC DEVICE.