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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 NamePROMOTE DEVICES & PROMOTE ACCEL DEVICES
Classification Namepulse generator, permanent, implantable
Generic Nametranstelephonic follow-up/monitoring system
ApplicantST. JUDE MEDICAL
PMA NumberP910023
Supplement NumberS243
Date Received07/13/2010
Decision Date09/09/2010
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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