CONCERTO MODELS C154DWK
FDA premarket approval P010031/S051 · decided 2006-11-15
Approval details
- PMA number
- P010031
- Supplement
- S051
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONCERTO MODELS C154DWK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-08-24
- Decision date
- 2006-11-15
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR SOFTWARE VERSION 1.1 WHICH ADDRESSES AN ISSUE OF TEMPERATURE SENSITIVITY ON TELEMETRY.
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