FDA PMA
30-Day Notice Accepted
🇺🇸 United States
PMA: P010031
·
Supplement: S123
·
Decision Oct 17, 2008
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- CONCERTO/CONSULTA/MAXIMO II
- PMA Number
- P010031
- Supplement Number
- S123
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- October 17, 2008
- Date Received
- September 19, 2008
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
CHANGE THE LASER RIBBON BONDING MANUFACTURING PROCESS.