Viva, Brava, Protecta, XT, Concerto, Concerto II, Maximo II, InSync II Protect, Amplia, Compia, Claria
FDA premarket approval P010031/S662 · decided 2019-06-11
Approval details
- PMA number
- P010031
- Supplement
- S662
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Viva, Brava, Protecta, XT, Concerto, Concerto II, Maximo II, InSync II Protect, Amplia, Compia, Claria
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-03-25
- Decision date
- 2019-06-11
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updates to firmware version 7.4 for Model 24950 MyCareLink monitors.
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