CONCERTO ICD,CONCERTO II CRT-D, CONSULTA DF4 ICD,CONSULTA, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D,
FDA premarket approval P010031/S323 · decided 2012-08-17
Approval details
- PMA number
- P010031
- Supplement
- S323
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO ICD,CONCERTO II CRT-D, CONSULTA DF4 ICD,CONSULTA, INSYNC III MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D,
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-07-25
- Decision date
- 2012-08-17
- Days to decision
- 23 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- NEW PRESSURE TEST EQUIPMENT USED TO VERIFY HERMETICITY.
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