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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.
 
DeviceMEDTRONIC IMPLANTABLE PROGRAMMABLE INFUSION PUMPS
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS202
Date Received01/28/2014
Decision Date02/25/2014
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR DEVICE REFILL KIT MODEL 8551TO REORDER THE WARNINGS AND PRECAUTIONS ACCORDING TO MEDICAL IMPORTANCE, TO REMOVE INFORMATION FOUND IN THE PREVIOUSLY APPROVED INSTRUCTIONS FOR USE THAT IS NOT APPLICABLE TO MODEL 8551, AND TO ALIGN VERBIAGE WITH THE UPDATED MODEL 856X REFILL KIT INSTRUCTIONS FOR USE.
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