PMA P010015S584
- Device
- Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S584
- Product code
- LWP
- Decision date
- 2026-03-27
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
Current openFDA PMA Record#
- Device
- Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S584
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2026-03-27
- Decision code
- OK30
- Date received
- 2026-03-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier