PMA P050023S199

Device: Acticor Sky HF-T 481986, Rivacor Sky HF-T 481991, Rivacor Rise HF-T 482017, Rivacor Aura HF-T 482013, Acticor Sky HF-T Q
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S199
Product code: MRM
Decision date: 2025-12-18
Classification: Cardiovascular
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: approval for the Acticor/Rivacor Sky families of Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, as well as updated programmer software versions PSW 2503.U and NEO 2503.U.

Current openFDA PMA Record#

Device: Acticor Sky HF-T 481986, Rivacor Sky HF-T 481991, Rivacor Rise HF-T 482017, Rivacor Aura HF-T 482013, Acticor Sky HF-T Q
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S199
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2025-12-18
Decision code: APPR
Date received: 2025-07-14
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for the Acticor/Rivacor Sky families of Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, as well as updated programmer software versions PSW 2503.U and NEO 2503.U.