CareLink SmartSync Percepta Serena Solara Application
FDA premarket approval P010015/S464 · decided 2021-02-12
Approval details
- PMA number
- P010015
- Supplement
- S464
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CareLink SmartSync Percepta Serena Solara Application
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2020-12-11
- Decision date
- 2021-02-12
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for software application release SmartSync Application Update Version 3.2.4..
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510(k) clearances by this applicant
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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