PMA P050023S194

Device: Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX,
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S194
Product code: MRM
Decision date: 2025-02-20
Classification: Cardiovascular
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: alternative supplier for manufacture of a subcomponent of medium-rate and high-rate batteries contained in implantable pulse generators (IPGs) and implantable cardioverter defibrillators (ICDs)

Current openFDA PMA Record#

Device: Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX,
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S194
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2025-02-20
Decision code: OK30
Date received: 2025-01-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: alternative supplier for manufacture of a subcomponent of medium-rate and high-rate batteries contained in implantable pulse generators (IPGs) and implantable cardioverter defibrillators (ICDs)