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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILIES OF PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS146
Date Received04/24/2007
Decision Date05/09/2007
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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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