Percepta Bipolar/Quadripolar CRT-P, Serena Bipolar/Quadripolar CRT-P, Solara Bipolar/Quadripolar CRT-P
FDA premarket approval P010015/S371 · decided 2018-06-05
Approval details
- PMA number
- P010015
- Supplement
- S371
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Percepta Bipolar/Quadripolar CRT-P, Serena Bipolar/Quadripolar CRT-P, Solara Bipolar/Quadripolar CRT-P
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2018-05-08
- Decision date
- 2018-06-05
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Add an alternate manufacturing site for the Surface Mount Technology Antenna.
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