Cardiac Resynchronization Therapy Pacemakers (CRT-P) Percepta Bipolar CRT-P, Percepta Quadtripolar CRT-P; Serena Bipolar
FDA premarket approval P010015/S396 · decided 2019-04-04
Approval details
- PMA number
- P010015
- Supplement
- S396
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cardiac Resynchronization Therapy Pacemakers (CRT-P) Percepta Bipolar CRT-P, Percepta Quadtripolar CRT-P; Serena Bipolar
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2019-03-05
- Decision date
- 2019-04-04
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Modification to the resistance spot welding process to the B+ electrical connector to the battery.
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