PMA P050023S213

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: S213
Product code: MRM
Decision date: 2026-10-09
Classification: Cardiovascular
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: battery separator pocket material change and new additive to battery electrolyte.

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: S213
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2026-10-09
Decision code: APPR
Date received: 2026-07-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: battery separator pocket material change and new additive to battery electrolyte.