PMA P000009S133

Device: Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T, Acticor 7 DR-T, Rivacor 7 DR-T, Rivacor 5 DR-T
Applicant: Biotronik, Inc.
PMA number: P000009
Supplement: S133
Product code: MRM
Decision date: 2026-09-25
Classification: Cardiovascular
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: to update manufacturing processes for high voltage capacitors in ICDs and CRT-Ds

Current openFDA PMA Record#

Device: Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T, Acticor 7 DR-T, Rivacor 7 DR-T, Rivacor 5 DR-T
Applicant: Biotronik, Inc.
PMA number: P000009
Supplement: S133
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2026-09-25
Decision code: OK30
Date received: 2026-08-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to update manufacturing processes for high voltage capacitors in ICDs and CRT-Ds