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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 and Endurity MRI Pacemakers
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP140033
Supplement NumberS051
Date Received11/25/2019
Decision Date12/06/2019
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Alternate supplier for the RF antenna and ribbon carrier components used in Scalable Brady Platform SR/DR pacemakers.
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