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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 PULSE GENERATOR MODEL DR 5370
Generic NameProgrammer, pacemaker
Regulation Number870.3700
ApplicantSt. Jude Medical, Inc.
15900 VALLEY VIEW Court
SYLMAR, CA 91342
PMA NumberP830045
Supplement NumberS079
Date Received10/29/2001
Decision Date11/27/2001
Withdrawal Date 06/20/2007
Product Code 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 PULSE GENERATOR MODEL DR 5370. THE DEVICE IS INDICATED IN THE FOLLOWING PERMANENT CONDITIONS, WHEN ASSOCIATED WITH SYMPTOMS INCLUDING, BUT NOT LIMITED TO: SYNCOPE, PRESYNCOPE, FATIGUE, DISORIENTATION OR ANY COMBINATION OF THESE SYMPTOMS. RATE-MODULATED PACING IS INDICATED FOR PATIENTS WITH CHRONOTROPIC INCOMPETENCE, AND FOR THOSE WHO WOULD BENEFIT FROM INCREASED STIMULATION RATES CONCURRENT WITH PHYSICAL ACTIVITY. 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 CLOCK WHEN TACHYARRHYTHMIA AND OTHER CAUSES HAVE BEEN RULED OUT. ATRIAL PACING IN 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 AV BLOCK OR SINUS ARREST; CHRONIC ATRIAL FIBRILLATION; AND SEVERE PHYSICAL DISABILITY.
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