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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSYNCHROMED, SYNCHROMED EL AND SYNCHROMED II IMPLANTABLE INFUSION SYSTEMS
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS126
Date Received04/20/2010
Decision Date10/06/2010
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for labeling changes to the synchromed, synchromed el and synchromed ii implantable infusion systems to specifically reference infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain, and prialt (preservative-free ziconotide sterile solution) for the management of severe chronic pain, identify the maximum concentration for infumorph, prialt and lioresal that can be delivered.
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