CONCERTO II CRT-D, CONSULTA DF4 ICD, ICD, MAXIMO IICRT-D, MAXIMO IIDF4 CRT-D
FDA premarket approval P010031/S320 · decided 2012-08-10
Approval details
- PMA number
- P010031
- Supplement
- S320
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2012-07-18
- Decision date
- 2012-08-10
- Days to decision
- 23 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATES TO THE NEXT GENERATION HYBRID TESTER SOFTWARE.
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