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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.
 
DeviceENDURITY FAMILY OF PACEMEKERS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS248
Date Received10/06/2014
Decision Date12/22/2014
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF NON-FUNCTIONAL JUMPER CONNECTIONS FOR THE HYBRID ASSEMBLIES UTILIZED IN THE DEVICES.
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