PMA P050023S198

Device: Acticor 7 VR-T 429526, Rivacor 7 VR-T 429536, Rivacor 5 VR-T 429565, Rivacor 3 VR-T 429574, Acticor 7 VR-T DX 429525, Ri
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S198
Product code: MRM
Decision date: 2025-06-18
Classification: Cardiovascular
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: to change the material of the feedthrough component of pacemaker and ICD batteries

Current openFDA PMA Record#

Device: Acticor 7 VR-T 429526, Rivacor 7 VR-T 429536, Rivacor 5 VR-T 429565, Rivacor 3 VR-T 429574, Acticor 7 VR-T DX 429525, Ri
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S198
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2025-06-18
Decision code: OK30
Date received: 2025-05-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to change the material of the feedthrough component of pacemaker and ICD batteries