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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 III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET
MS MVS11
MOUNDS VIEW, MN 55112
PMA NumberP980050
Supplement NumberS015
Date Received12/12/2003
Decision Date04/12/2004
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974. THE DEVICE IS INDICATED AS FOLLOWS: THE MODEL 7276 GEM III AT WITH APP IS INDICATED FOR USE IN ICD PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IS INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIAS. IN ADDITION, THE DEVICE IS INTENDED TO PROVIDE PACING, CARDIOVERSION, AND DEFIBRILLATION FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC, DRUG-REFRACTORY ATRIAL FIBRILLATION, AND/OR LIFE THREATENING VENTRICULAR TACHYARRHYTHMIAS. ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP) AND POST MODE SWITCH OVERDRIVE (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN ICD-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND ONE OR MORE OF THE ABOVE ICD INDICATIONS. NOTES: THE USE OF THE DEVICE HAS NOT BEEN DEMONSTRATED TO DECREASE THE MORBIDITY RELATED TO ATRIAL TACHYARRHYTHMIAS. THE EFFECTIVENESS OF HIGH FREQUENCY BURST PACING (ATRIAL-50 HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 17%, AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO BE 16.8%, IN THE VT/AT PATIENT POPULATION STUDIED. THE EFFECTIVENESS OF HIGH FREQUENCY BURST PACING (ATRIAL-50 HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 11.7%, AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO BE 18.2%, IN THE AF-ONLY PATIENT POPULATION STUDIED.
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