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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 NameAFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILIES OF PACEMAKERS
Classification Namepulse generator, permanent, implantable
Generic Nametiered therapy implantable defibrillator
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP880086
Supplement NumberS146
Date Received04/24/2007
Decision Date05/09/2007
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the zephyr xl sr model 5626 pacemaker which utilizes the xl battery model 9438 which is currently approved for use with the marketed zephyr xl dr 5826 pacemaker. The device, as modified, will be marketed under the trade name zephyr xl sr model 5626 and is indicated for single chamber rate adaptive pacing.
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