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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDRUG DELIVERY CATHETERS, DRUG DELIVERY KITS FOR REVISIONS
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
PMA NumberP990034
Supplement NumberS032
Date Received06/04/2014
Decision Date07/03/2014
Product Code
LKK[ Registered Establishments with 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 
Manufacturing change associated with incoming inspection activities.
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