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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.
 
DeviceMicrony family of Pacemakers
Generic NamePulse-generator, single chamber, sensor driven, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP970013
Supplement NumberS092
Date Received02/01/2023
Decision Date04/14/2023
Product Code LWO 
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 software changes in the Merlin PCS Model 3330 Software v27.0.1 and Merlint.net MN5000 v8.0.
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