PMA P000009S091

Device: Defibrillator, Implantable Dual-Chamber
Applicant: Biotronik, Inc.
PMA number: P000009
Supplement: S091
Product code: MRM
Decision date: 2021-06-02
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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: Defibrillator, Implantable Dual-Chamber
Applicant: Biotronik, Inc.
PMA number: P000009
Supplement: S091
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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.