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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 NameACCENT DR, ACCENT DR RF, ACCENT SR, ACCENT SR RF PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL
PMA NumberP880086
Supplement NumberS236
Date Received11/05/2013
Decision Date12/04/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate burn-in (bi) for the environmental screening during the manufacture of pacemaker and crt-p hybrid assemblies.
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