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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 NumberS032
Date Received04/11/2019
Decision Date07/10/2019
Withdrawal Date 08/18/2021
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 minor design and related minor manufacturing changes to the pumphead roller arm assembly of the SynchroMed® II Pump for Implantable System for Remodulin.
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