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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.
 
DeviceIsoMed Infusion System
Generic Namepump, infusion, implanted, programmable
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP990034
Supplement NumberS038
Date Received01/30/2018
Decision Date03/01/2018
Product Code LKK 
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the sterilization process for the impacted catheter access and refill accessory kits.
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