PMA P050023S103

Device: Various models of dual chamber ICDS in the Ilivia, Intica, Inlexa Families, Various models of CRT-Ds and Non- CRT-Ds in
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S103
Product code: MRM
Decision date: 2017-05-03
Classification: Defibrillator, Implantable, Dual-chamber
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: Approval for the Ilivia, Intica and Inlexa families of ICDs and CRT-Ds, BS IS4 Blind Plug, as well as associated software updates PSW 1602.U and HMSC 3.34.0.

Current openFDA PMA Record#

Device: Various models of dual chamber ICDS in the Ilivia, Intica, Inlexa Families, Various models of CRT-Ds and Non- CRT-Ds in
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S103
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2017-05-03
Decision code: APPR
Date received: 2016-07-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Ilivia, Intica and Inlexa families of ICDs and CRT-Ds, BS IS4 Blind Plug, as well as associated software updates PSW 1602.U and HMSC 3.34.0.