FDA PMA
30-Day Notice Accepted
🇺🇸 United States
PMA: P010031
·
Supplement: S321
·
Decision Aug 14, 2012
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D
- PMA Number
- P010031
- Supplement Number
- S321
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 14, 2012
- Date Received
- July 19, 2012
- Supplement Type
- 30-Day Notice
- Expedited Review
- N
Advisory Committee Statement
UPDATES TO THE HYBRID TESTING PROCESS.