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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 SR+ Regency SC+
Generic NamePulse-generator, single chamber, sensor driven, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP970013
Supplement NumberS070
Date Received02/07/2017
Decision Date10/20/2017
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 the Merlin Patient Care System (PCS) Model 3330 version 23.0.1 Software for the Merlin PCS Model 3650 Programmer.
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