FDA PMA
30-Day Notice Accepted
🇺🇸 United States
PMA: P010031
·
Supplement: S221
·
Decision Dec 23, 2010
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO II CRT-D
- PMA Number
- P010031
- Supplement Number
- S221
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 23, 2010
- Date Received
- December 7, 2010
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
UPGRADE TO THE RADIO FREQUENCY MODULE TEST SYSTEM.