- Device
- Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S574
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2025-12-19
- Decision code
- APPR
- Date received
- 2025-09-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a material change in the pulse generator header components of select CRT-D and CRT-P devices.