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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.
 
DeviceSynchroMed Infusion System
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS300
Date Received03/19/2018
Decision Date06/13/2018
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for software changes to Medtronic’s Model A810 SynchroMed II Clinician Programmer Application including the Advanced Prime and Single Bolus feature and resolving anomalies.
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