CaareLink SmartSync Percepta Serena Solara Application, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipol
FDA premarket approval P010015/S430 · decided 2020-05-17
Approval details
- PMA number
- P010015
- Supplement
- S430
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CaareLink SmartSync Percepta Serena Solara Application, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipol
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2020-02-28
- Decision date
- 2020-05-17
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for CareLink SmartSync Common Application version 3.2.01, CareLink SmartSync Azure Astra Application version 3.2.02, CareLink SmartSync Percepta Serena Solara Application version 3.2.02.
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