PMA P070008S125

Device: Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P)
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S125
Product code: NKE
Decision date: 2021-06-02
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: Addition of an alternative supplier for a battery subcomponent and the automation of a process used in the manufacture of medium and high-rate batteries.

Current openFDA PMA Record#

Device: Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P)
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S125
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2021-06-02
Decision code: OK30
Date received: 2021-05-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternative supplier for a battery subcomponent and the automation of a process used in the manufacture of medium and high-rate batteries.