- Device
- Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Biplar CRT-P, Serena Quadripolar CRT-P, Solar
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S472
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-04-12
- Decision code
- OK30
- Date received
- 2021-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process changes for the use of the dadet used in feedthrough assembly.