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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 FOR THE INTRATHECAL ADMINISTRATION OF PRIALT (ZICONOTIDE)
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS066
Date Received01/21/2005
Decision Date02/14/2005
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE INTRATHECAL ADMINISTRATION OF PRIALT (ZICONOTIDE). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SYNCHROMED IMPLANTABLE INFUSION SYSTEM AND IS INDICATED FOR THE CHRONIC INTRATHECAL INFUSION OF PRESERVATIVE-FREE ZICONOTIDE STERILE SOLUTION FOR THE MANAGEMENT OF SEVERE, CHRONIC PAIN.
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