PMA P050023

Device: Ilivia 7 VRT DX, Intica 7 VRT DX, Intica 5 VRT DX, Ilivia 7 VRT, Intica 7 VRT, Intica 5 VRT, Inlexa 7 VRT, Inlexa 7 VRT
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S170
Product code: MRM
Decision date: 2026-10-22
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: updating visual and dimensional incoming inspection testing for certain components and raw materials used in IPG, ICD, and lead manufacturing

Current openFDA PMA Record#

Device: Ilivia 7 VRT DX, Intica 7 VRT DX, Intica 5 VRT DX, Ilivia 7 VRT, Intica 7 VRT, Intica 5 VRT, Inlexa 7 VRT, Inlexa 7 VRT
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S216
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2026-10-22
Decision code: OK30
Date received: 2026-09-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updating visual and dimensional incoming inspection testing for certain components and raw materials used in IPG, ICD, and lead manufacturing