PMA P050023S200

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 (4
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S200
Product code: MRM
Decision date: 2025-09-11
Classification: Cardiovascular
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: updates to visual inspection acceptance criteria for seal coupler outer sealing lips of 4-pole modules

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 (4
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S200
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2025-09-11
Decision code: OK30
Date received: 2025-08-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updates to visual inspection acceptance criteria for seal coupler outer sealing lips of 4-pole modules