PMA P070008S184

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
Decision date: 2026-10-22
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: updating visual and dimensional incoming inspection testing for certain components and raw materials used in IPG, ICD, and lead manufacturing

Current openFDA PMA Record#

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