CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF4 CRT-D, PROTECTA CRT-D, PROTECTA DF4 CR
FDA premarket approval P010031/S341 · decided 2012-12-11
Approval details
- PMA number
- P010031
- Supplement
- S341
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF4 CRT-D, PROTECTA CRT-D, PROTECTA DF4 CR
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-11-16
- Decision date
- 2012-12-11
- Days to decision
- 25 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADD HIGH TEMPERATURE MONITOR TO HIGH POWER LEAN LINE.
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