PMA P050023S190

Device: Ilivia 7 HF-T, Intica 7/5 HF-T, Acticor 7 HF-T, Rivacor 7/5/3 HF-T, Ilivia 7 HF-T QP, Initca 7 HF-T QP, Acticor 7 HF-T Q
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S190
Product code: MRM
Decision date: 2025-03-10
Classification: Cardiovascular
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: approval to expand MR conditional scan durations for system configurations including Pamira and Plexa ICD leads

Current openFDA PMA Record#

Device: Ilivia 7 HF-T, Intica 7/5 HF-T, Acticor 7 HF-T, Rivacor 7/5/3 HF-T, Ilivia 7 HF-T QP, Initca 7 HF-T QP, Acticor 7 HF-T Q
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S190
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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