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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, SYNCHROMED EL AND SYNCHROMED II IMPLANTABLE INFUSION SYSTEMS
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS126
Date Received04/20/2010
Decision Date10/06/2010
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
Predetermined Change Control Plan AuthorizedNo
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-FREEZICONOTIDE 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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