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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.
 
DeviceSYNCHROMED INFUSION SYSTEM
Generic Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS265
Date Received12/06/2016
Decision Date02/24/2017
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  
New supplier of the retaining ring component within the Drug Delivery Catheters (model 8780, 8781, 8731SC) and Drug Delivery Kits for Revisions (model 8578, 8596SC, 8784).
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