- Device
- Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S184
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2026-10-22
- Decision code
- OK30
- Date received
- 2026-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updating visual and dimensional incoming inspection testing for certain components and raw materials used in IPG, ICD, and lead manufacturing