- Device
- STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S121
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2020-12-18
- Decision code
- OK30
- Date received
- 2020-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement automated cleaning equipment during an intermediate cleaning step