PMA P070008S173

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: S173
Product code: NKE
Decision date: 2025-12-10
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: to introduce fractal iridium coating of pacing lead components at BIOTRONIK APM

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: S173
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2025-12-10
Decision code: OK30
Date received: 2025-11-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to introduce fractal iridium coating of pacing lead components at BIOTRONIK APM