- Device
- Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S486
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-12-07
- Decision code
- OK30
- Date received
- 2021-11-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the manufacturing execution system (MES) to FACTORYworks (FW) Release 9.9.