PMA P050023S033

Device: VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S033
Product code: MRM
Decision date: 2010-11-26
Classification: Defibrillator, Implantable, Dual-chamber
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: APPROVAL FOR THE ATRIAL CAPTURE CONTROL AND VENTRICULAR PACING SUPPRESSION FEATURES INCLUDED IN VERSION 1002.U/1 PROGRAMMER SOFTWARE FOR THE EVIA/ENTOIS PULSE GENERATORS.

Current openFDA PMA Record#

Device: VARIOUS MODELS OF LUMAX ICD/CRT-D FAMILIES
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S033
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2010-11-26
Decision code: APPR
Date received: 2010-06-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ATRIAL CAPTURE CONTROL AND VENTRICULAR PACING SUPPRESSION FEATURES INCLUDED IN VERSION 1002.U/1 PROGRAMMER SOFTWARE FOR THE EVIA/ENTOIS PULSE GENERATORS.