PMA P980023S149

Device: Acticor Sky VR-T 481989; Rivacor Sky VR-T 481984; Rivacor Rise VR-T 482020; Rivacor Aura VR-T 482015; Acticor Sky VR-T D
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S149
Product code: LWS
Decision date: 2026-10-09
Classification: Cardiovascular
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: battery separator pocket material change and new additive to battery electrolyte.

Current openFDA PMA Record#

Device: Acticor Sky VR-T 481989; Rivacor Sky VR-T 481984; Rivacor Rise VR-T 482020; Rivacor Aura VR-T 482015; Acticor Sky VR-T D
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S149
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
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.