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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 NumberS026
Date Received01/09/2019
Decision Date02/04/2019
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Changes to the Implantable System for Remodulin, including the implantable catheter, implantable catheter and revision kit, and the implantable infusion pump, which includes minor changes to the specification documentation, incoming inspection, manufacturing process and manufacturing validation.
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