PMA P950037S274

Device: Solia S 53 377177; Solia S 60 377179
Applicant: Biotronik, Inc.
PMA number: P950037
Supplement: S274
Product code: DXY
Decision date: 2025-12-18
Classification: Cardiovascular
Generic name: implantable pacemaker Pulse-generator
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: Solia S 53 377177; Solia S 60 377179
Applicant: Biotronik, Inc.
PMA number: P950037
Supplement: S274
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
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.