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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 Pkwy. NE
Minneapolis, MN 55432
PMA NumberP140032
Supplement NumberS051
Date Received03/11/2020
Decision Date04/07/2020
Withdrawal Date08/18/2021
Product Code LKK 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changes to the restock evaluation location and process for the SynchroMed II Infusion System. Restock processing for the product moved from the Rice Creek Facility to Medtronic's Distribution Centers and restock evaluation for the product has transitioned to evaluation using the Distribution Center Sorter Tool.
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