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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC MODEL 7278 MAXIMO DR ICD AND MODEL 7232 MAXIMO VR ICD SYSTEMS, WITH MODEL 9978 VERSION 1.0 APPLICATION SOFTWA
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MS MVS11
MOUNDS VIEW, MN 55112
PMA NumberP980016
Supplement NumberS037
Date Received09/08/2003
Decision Date10/06/2003
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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.
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