- Device
- Viva, Brava, Protecta, XT, Concerto, Concerto II, Maximo II, InSync II Protect, Amplia, Compia, Claria
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S662
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2019-06-11
- Decision code
- APPR
- Date received
- 2019-03-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to firmware version 7.4 for Model 24950 MyCareLink monitors.