PMA P050023S011

Device: KRONOS LV-T CRT-D
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S011
Product code: MRM
Decision date: 2008-11-04
Classification: Defibrillator, Implantable, Dual-chamber
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: APPROVAL FOR THE ADDITION OF MODELS 500/540 TO THE LUMAX FAMILY OF ICD/CRT-DS AND ICS 3000 PROGRAMMER. THESE MODELS WOULD CONTAIN:¿ A THIRD PROGRAMMABLE CARDIOVERSION / DEFIBRILLATION SHOCK PATHWAY TO OFFER MOREPROGRAMMING OPTIONS¿ AUTOMATIC THRESHOLD MEASUREMENT (ATM) FEATURE ¿ ELECTRONIC MODULE (HARDWARE) UPDATES TO SUPPORT THE THIRD PROGRAMMABLE SHOCK PATH¿ MODIFICATIONS TO THE LITRONIK BATTERIES TO INCREASE CAPACITY¿ NEW STANDARD VALUE OF THE PROGRAMMABLE PACING PULSE WIDTH¿ UPDATED RAM FIRMWARE TO SUPPORT NEW FEATURES

Current openFDA PMA Record#

Device: KRONOS LV-T CRT-D
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S011
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2008-11-04
Decision code: APPR
Date received: 2008-05-14
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF MODELS 500/540 TO THE LUMAX FAMILY OF ICD/CRT-DS AND ICS 3000 PROGRAMMER. THESE MODELS WOULD CONTAIN:¿ A THIRD PROGRAMMABLE CARDIOVERSION / DEFIBRILLATION SHOCK PATHWAY TO OFFER MOREPROGRAMMING OPTIONS¿ AUTOMATIC THRESHOLD MEASUREMENT (ATM) FEATURE ¿ ELECTRONIC MODULE (HARDWARE) UPDATES TO SUPPORT THE THIRD PROGRAMMABLE SHOCK PATH¿ MODIFICATIONS TO THE LITRONIK BATTERIES TO INCREASE CAPACITY¿ NEW STANDARD VALUE OF THE PROGRAMMABLE PACING PULSE WIDTH¿ UPDATED RAM FIRMWARE TO SUPPORT NEW FEATURES