PMA P010015S575
- 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
- S575
- Product code
- LWP
- Decision date
- 2025-12-03
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- an update to the substrate defect mapping process
Current openFDA PMA Record#
- 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
- S575
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2025-12-03
- Decision code
- OK30
- Date received
- 2025-11-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update to the substrate defect mapping process