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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
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS, MN 55432-5604
PMA NumberP140032
Supplement NumberS002
Date Received02/01/2018
Decision Date04/17/2018
Withdrawal Date 08/18/2021
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 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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