Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02, W4TR02; Solara Bipolar CRT
FDA premarket approval P010015/S332 · decided 2017-06-08
Approval details
- PMA number
- P010015
- Supplement
- S332
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02, W4TR02; Solara Bipolar CRT
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2017-05-18
- Decision date
- 2017-06-08
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Additional vision system for inspection of final packaged devices.
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