Percepta, Serena, Solara Bipolar/Quadripolar CRT-P
FDA premarket approval P010015/S338 · decided 2017-08-29
Approval details
- PMA number
- P010015
- Supplement
- S338
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Percepta, Serena, Solara Bipolar/Quadripolar CRT-P
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2017-07-14
- Decision date
- 2017-08-29
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for minor design changes and manufacturing documentation changes related to the hybrid integrated circuits.
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