PMA P980023

Device: Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky VR-T DX, Riva
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S118
Product code: LWS
Decision date: 2026-09-17
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: approval for updated programmer software PSW 2601.U and NEO 2601.U

Current openFDA PMA Record#

Device: Acticor Sky VR-T, Rivacor Sky VR-T, Rivacor Rise VR-T, Rivacor Aura VR-T, Acticor Sky VR-T DX, Rivacor Sky VR-T DX, Riva
Applicant: Biotronik, Inc.
PMA number: P980023
Supplement: S146
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2026-09-17
Decision code: APPR
Date received: 2026-04-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for updated programmer software PSW 2601.U and NEO 2601.U