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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 PARKWAY NE
MINNEAPOLIS, MN 55432-5604
PMA NumberP140032
Supplement NumberS072
Date Received05/28/2021
Decision Date06/25/2021
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  
approval to the newly defined and characterized solder paste inspection (SPI) process at Medtronic Tempe Campus (MTC), Medtronic’s internal supplier of hybrids used in the manufacturing of Medtronic Neuromodulation (Neuro) products
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