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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.
 
DeviceImplantable System for Remodulin
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
Medtronic, Inc.
710 medtronic parkway ne
minneapolis, MN 55432-5604
PMA NumberP140032
Supplement NumberS002
Date Received02/01/2018
Decision Date04/17/2018
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes made to the design history file and device master record of the motor component of the SynchroMed II Implantable System for Remodulin, (Model 8637P), 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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