Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, and Solara Quadripolar dual
FDA premarket approval P010015/S456 · decided 2021-01-28
Approval details
- PMA number
- P010015
- Supplement
- S456
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, and Solara Quadripolar dual
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2020-11-02
- Decision date
- 2021-01-28
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for software updates necessary for release of software application releases SW030 (Orion) v8.2 and SW040 (CRT-P Quad) v8.4.
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