FDA PMA
Approved
🇺🇸 United States
PMA: P010031
·
Supplement: S127
·
Decision Mar 9, 2009
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- CONCERTO
- PMA Number
- P010031
- Supplement Number
- S127
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 9, 2009
- Date Received
- October 2, 2008
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MODIFICATIONS TO THE HYBRID PRESS FIXTURE.