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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 Implantable Infusion System
Generic Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS270
Date Received03/14/2017
Decision Date04/13/2017
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 labeling changes to Medtronic SynchroMed® II and IsoMed® Implant Infusion system labeling associated with Over-infusion, Allergic Reaction, Tunneling Risks, Priapism, Magnetic Resonance Imaging.
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