FDA PMA
30-Day Notice Accepted
🇺🇸 United States
PMA: P010031
·
Supplement: S265
·
Decision Aug 4, 2011
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- CONCERTO II/CONSULTA/MAXIMO II
- PMA Number
- P010031
- Supplement Number
- S265
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 4, 2011
- Date Received
- July 8, 2011
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
SOFTWARE UPGRADE FOR THE MANUFACTURING EXECUTION SYSTEM.