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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, Zenus MRI, Zenex MRI
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantABBOTT MEDICAL
15900 Valley View Ct.
Sylmar, CA 91335
PMA NumberP140033
Supplement NumberS083
Date Received12/08/2023
Decision Date02/28/2024
Product Codes LWP NVN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Your supplement requested approval for replacing a laminate frame encapsulation method with a frameless dam-and-fill method in the hybrid of Scalable Brady Platform pacemakers.
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