- 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
- S446
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-08-24
- Decision code
- OK30
- Date received
- 2020-07-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Tighten the material controls of fluorinated carbon material received from an external supplier.