CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D
FDA premarket approval P010031/S321 · decided 2012-08-14
Approval details
- PMA number
- P010031
- Supplement
- S321
- Supplement type
- 30-Day Notice
- Trade name
- CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-07-19
- Decision date
- 2012-08-14
- Days to decision
- 26 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATES TO THE HYBRID TESTING PROCESS.
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