PMA P070008S174

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: S174
Product code: NKE
Decision date: 2026-02-03
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: removal of redundant incoming inspection from certain qualified suppliers

Current openFDA PMA Record#

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: S174
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2026-02-03
Decision code: OK30
Date received: 2026-01-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: removal of redundant incoming inspection from certain qualified suppliers