- 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
- S468
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-03-08
- Decision code
- OK30
- Date received
- 2021-02-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of receiving and incoming inspection activities for a device component from Medtronic Rice Creek facility to the Medtronic Puerto Rico Operations Company Junco site and the FedEx/3PL facility in Guaynabo, Puerto Rico.