- Device
- CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P010031
- Supplement
- S737
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2021-05-27
- Decision code
- APPR
- Date received
- 2021-03-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for new cardiovascular implantable electronic device (CIED) software applications on the CareLink SmartSync Device Manager.