FDA PMA
30-Day Notice Accepted
🇺🇸 United States
PMA: P010031
·
Supplement: S323
·
Decision Aug 17, 2012
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- CONCERTO ICD,CONCERTO II CRT-D, CONSULTA DF4 ICD,CONSULTA, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D,
- PMA Number
- P010031
- Supplement Number
- S323
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 17, 2012
- Date Received
- July 25, 2012
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
NEW PRESSURE TEST EQUIPMENT USED TO VERIFY HERMETICITY.