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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 NumberS036
Date Received07/11/2019
Decision Date10/02/2019
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a shelf life extension of the Model 845PAH Catheter Patency Kit shelf life from 24 months to 48 months.
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