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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 NumberS057
Date Received06/01/2020
Decision Date09/22/2020
Withdrawal Date08/18/2021
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for change to improve the final product yield in the final pack manufacturing step to confirm telemetry of the SynchroMed II Implantable Infusion Pump Model 8637 for the Implantable System for Remodulin.
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