- Device
- Corox (ProMRI) OTW 75 BP, Corox (ProMRI) OTW-S 75 BP, Corox (ProMRI) OTW-L 75 BP, Corox (ProMRI) OTW 85 BP, Corox (ProMR
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S163
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2025-03-10
- Decision code
- APPR
- Date received
- 2024-12-10
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval to expand MR conditional scan durations for system configurations including Pamira and Plexa ICD leads