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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 GEM ICD
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP900061
Supplement NumberS049
Date Received09/26/2001
Decision Date03/13/2002
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC/VITATRON CARELINK PROGRAMMER MODEL 2090, MODEL 2067 CARELINK PROGRAMMER RF HEAD, MODEL 2290 LEAD ANALYZER, MODEL 2292 ANALYZER CABLE, MODEL 2091 CARELINK PROGRAMMER MODEM, MODEL 8190 SOFTWARE FOR THE MODEL 2290 LEAD ANALYZER, MODEL 5437A PROGRAMMER INTERFACE CABLE, MODEL 2090 EC ECG CABLE, MODEL 2090 AB CABLE, MODEL 2090 TPS TOUCHPEN, MODEL 2090 RV REMOTE VIEW SOFTWARE, MODEL 9964 CARELINK PROGRAMMER SOFTWARE FOR THE GEM II DR ICD (MODEL 7273), MODEL 9966 CARELINK PROGRAMMER SOFTWARE FOR THE MARQUIS DR ICD, MODEL 9896 CARELINK PROGRAMMER SOFTWARE FOR THE JEWEL (MODEL 7218), AND VITATRON MODEL VSC02 VERSION 6.1 CARELINK PROGRAMMER SOFTWARE. IN ADDITION, THIS SUBMISSION INCLUDES THE FOLLOWING PROGRAMMER SOFTWARE APPLICATIONS (PREVIOUSLY APPROVED FOR OTHER MEDTRONIC, VITATRON, OR CPI PROGRAMMERS) THAT HAVE BEEN MODIFIED FOR USE WITH THE MODEL 2090 CARELINK PROGRAMMER: VITATRON PROVIT MODEL VSA02 V6.1, KAPPA 400 (9952/A), KAPPA 600/700 (9953/A), KAPPA 800/900 (9988), SIGMA (9963/A), INSYNC (9980), REVEAL PLUS (9809), ANALYZER (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), BASELINE 7 (9891/A), CPI PRELUDE (9892), CPI TRIUMPH (9892), JEWEL PCD (9895), JEWEL CD (9895), JEWEL AF (9961), JEWEL PLUS (9895), PCD (9895), PREVA D, ST-DR (9959, JEWEL (9894), JEWEL II (9955). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC/ VITATRON CARELINK PROGRAMMER MODEL 2090 AND IS INDICATED FOR USE IN THE INTERROGATION AND PROGRAMMING OF IMPLANTABLE MEDICAL DEVICES.
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