- 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
- S582
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2026-03-06
- Decision code
- OK30
- Date received
- 2026-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to replace the Novec 72DA solvent with the PWR-4 3910 solvent during the component cleaning process