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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 NameIDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF PACEMAKER DEVICES
Classification Namepulse generator, permanent, implantable
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL
PMA NumberP880086
Supplement NumberS231
Date Received12/11/2012
Decision Date04/23/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of a second source supplier for anchors used in the firms icd, crt-d, pacemaker, and crt-p devices.
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