- Device
- Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S459
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-12-16
- Decision code
- OK30
- Date received
- 2020-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a new software check system that occurs after the wafer test steps at Medtronic Tempe Campus.