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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 NameTRILOGY FAMILY OF PULSE GENERATORS
Classification Nameimplantable pacemaker pulse-generator
Generic Namecardiac pacemaker
Regulation Number870.3610
ApplicantST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
PMA NumberP880086
Supplement NumberS056
Date Received10/02/1998
Decision Date11/03/1998
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the insulating ring surrounding the negative pin of the battery in trilogy pacers.
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