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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 NamePACEMAKER AND CRT-P DEVICES
Classification Namepulse generator, permanent, implantable
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880086
Supplement NumberS205
Date Received06/08/2011
Decision Date07/22/2011
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the seal plug for the setscrew (referred to as the septum in the submission).
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