|Trade Name||MEDTRONIC MODEL 7278 MAXIMO DR ICD AND MODEL 7232 MAXIMO VR ICD SYSTEMS, WITH MODEL 9978 VERSION 1.0 APPLICATION SOFTWA|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||dual chamber icds|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to modify the marquis vr and dr systems to provide increased energy output (35j). The devices will be used with the following application software versions: model 9978 version 1. 0 application software for use with the maximo dr, and model 9979 version 1. 0 application software for use with maximo vr. The application software may be installed on either 9790c or 2090 programmers. The devices, as modified, will be marketed under the trade name maximo dr/vr icd system and are indicated as follows: the implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.