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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.
 
DeviceIDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A
Generic NameProgrammer, pacemaker
ApplicantSt. Jude Medical, Inc.
15900 VALLEY VIEW Court
SYLMAR, CA 91342
PMA NumberP830045
Supplement NumberS085
Date Received03/03/2003
Decision Date03/20/2003
Withdrawal Date 06/20/2007
Product Codes DXY KRG 
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 IDENTITY ADX MODELS XL DR 5386 AND DR 5380 PULSE GENERATORS AND PROGRAMMER SOFTWARE MODEL 3307 V4.2A. THESE DEVICES ARE INDICATED AS FOLLOWS: IMPLANTATION OF IDENTITY ADX MODELS5386 AND 5380 PULSE GENERATORS IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION, OR ANY COMBINATION OF THOSE SYMPTOMS. DUAL-CHAMBER PACING IS INDICATED FOR THOSE PATIENTS EXHIBITING: SICK SINUS SYNDROME, CHRONIC SYMPTOMATIC SECOND- AND THIRD-DEGREE AV BLOCK, RECURRENT ADAMS-STOKES SYNDROME, AND SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT. ATRIAL PACING IS INDICATED FOR PATIENTS WITH SINUS NODE DYSFUNCTION AND NORMAL AV AND INTRAVENTRICULAR CONDUCTION SYSTEMS. VENTRICULAR PACING IS INDICATED FOR PATIENTS WITH SIGNIFICANT BRADYCARDIA AND: NORMAL SINUS RHYTHM WITH ONLY RARE EPISODES OF A-V BLOCK OR SINUS ARREST, CHRONIC ATRIAL FIBRILLATION AND SEVERE PHYSICAL DISABILITY. AF SUPPRESSION IS INDICATED FOR SUPPRESSION OF PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION EPISODES IN PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.
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