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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 (ISR)
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS, MN 55432-5604
PMA NumberP140032
Supplement NumberS011
Date Received05/16/2018
Decision Date06/15/2018
Withdrawal Date 08/18/2021
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
Approval Order Statement  
Changes Medtronic Implantable System for Remodulin® (ISR) including changes to the manufacturing process and suppliers for the ISR pump, components and processes for the ISR catheter and changes to the number of nitrogen purges for the ISR Refill Kit.
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