PMA P950037S267

Device: Safio S 53, Setrox S 53, Solia S 45, Solia S 53, Solia S 60, Siello S 45, Siello S 53, Siello S 60
Applicant: Biotronik, Inc.
PMA number: P950037
Supplement: S267
Product code: DXY
Decision date: 2025-03-10
Classification: Cardiovascular
Generic name: implantable pacemaker Pulse-generator
Approval order statement: approval to expand MR conditional scan durations for system configurations including Pamira and Plexa ICD leads

Current openFDA PMA Record#

Device: Safio S 53, Setrox S 53, Solia S 45, Solia S 53, Solia S 60, Siello S 45, Siello S 53, Siello S 60
Applicant: Biotronik, Inc.
PMA number: P950037
Supplement: S267
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2025-03-10
Decision code: APPR
Date received: 2024-12-10
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval to expand MR conditional scan durations for system configurations including Pamira and Plexa ICD leads