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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.
 
DeviceAssurity MRI, Endurity MRI
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP140033
Supplement NumberS076
Date Received09/08/2022
Decision Date12/07/2022
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for MR Conditional labeling for IsoFlex pacing leads when combined with the Assurity MRI and Endurity MRI single and dual chamber implantable pulse generators.
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