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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 MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS WITH
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 NumberS029
Date Received06/28/2002
Decision Date12/17/2002
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MEDTRONIC MODELS 7230CX, 7230B, AND 7230E MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS WITH MODEL 9967 (MARQUIS VR) APPLICATION SOFTWARE FOR USE WITH THE COMMERCIALLY AVAILABLE MODEL 9322 PATIENT MAGNET, THE MODEL 9790C PROGRAMMING SYSTEM [9790C PROGRAMMER, MODEL 9990 DESKTOP SOFTWARE AND MODEL 9767/9767L TELEMETRY PROGRAMMING HEAD (TELEMETRY B)] AND WITH THE MODEL 2090 PROGRAMMING SYSTEM [2090 PROGRAMMER, MODEL 9986 DESKTOP SOFTWARE AND MODEL 2067/2067L TELEMETRY PROGRAMMING HEAD (TELEMETRY PROGRAMMING HEAD (TELEMETRY B)]. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MARQUIS VR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.
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