FDA PMA
30-Day Notice Accepted
🇺🇸 United States
PMA: P010031
·
Supplement: S118
·
Decision Sep 17, 2008
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- CONCERTO/MAXIMO II/CONSULTA
- PMA Number
- P010031
- Supplement Number
- S118
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- September 17, 2008
- Date Received
- August 18, 2008
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
REPLACEMENT OF EXISTING, OBSOLETE EPOXY DISPENSER WITH NEW EQUIPMENT.