Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solar Bipolar CRT-P,
FDA premarket approval P010015/S357 · decided 2018-05-21
Approval details
- PMA number
- P010015
- Supplement
- S357
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solar Bipolar CRT-P,
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2018-03-07
- Decision date
- 2018-05-21
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a minor firmware design change for the Percepta/Percepta Quad CRT-P MRI SureScan devices.
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