- Device
- Consulta CRT-P,Percepta Bipolar CRT-P,Percepta Quadripolar CRT-P,Serena Bipolar CRT-P,Serena Quadripolar CRT-P,Solara Bi
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S436
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-06-08
- Decision code
- OK30
- Date received
- 2020-05-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify final visual inspection requirements for hybrid modules.