PMA P050023S195

Device: Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S195
Product code: MRM
Decision date: 2025-03-05
Classification: Cardiovascular
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: an alternative supplier, replacement material, and updated processing steps for battery manufacturing

Current openFDA PMA Record#

Device: Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S195
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2025-03-05
Decision code: OK30
Date received: 2025-02-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative supplier, replacement material, and updated processing steps for battery manufacturing