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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMODEL 9602 PROGRAMMER
Classification Nameimplantable pacemaker pulse-generator
Generic Namepacemaker
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP880038
Supplement NumberS034
Date Received04/24/1997
Decision Date04/29/1997
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing site for the model 9602 programmer. The site is located at pacesetter, inc. , 15900 valley view ct. , sylmar ca.
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