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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 NumberS284
Date Received07/17/2017
Decision Date09/26/2017
Product Code LKK 
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
minor specification and material changes to the antenna wire and solder composition used in the model 37092 External Antenna, as well as minor manufacturing changes and minor design changes to the exterior mold
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