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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 NumberS275
Date Received04/27/2017
Decision Date12/21/2017
Product Code LKK 
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for changes made to the design history file and device master record of the motor component of the SynchroMed II Programmable Drug Infusion Pump (Model 8637), the associated parts of the motor (i.e. assemblies, subassemblies, components, subcomponents, and materials used in the manufacturing of the motor assembly), and the pumphead assembly material specifications.
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