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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.
 
DeviceMEDTRONIC SYNCHROMED INFUSION SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS035
Date Received05/08/1996
Decision Date09/10/1996
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ADD TO THE LABELING FOR THE 10 CC SYNCHROMED IMPLANTABLE PROGRAMMABLE INFUSION PUMP, MOELS 8616-10 AND 8617-10 THE FOLLOWING INDICATIONS:1)THE CHRONIC INTRASPINAL (EPIDURAL/INTRATHECAL) INFUSION OF PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION IN THE TREATEMTN OF CHRONIC INTRACTABLE PAIN; 2)THE CHRONIC INTRAVASCULAR INFUSION OF FLOXURIDINE, DOXORUBICIN, CISPLATIN, OR METHOTREXATE FOR THE TREATEMENT OF PRIMARY OR METASTATIC CANCER; AND 3)THE INTRAVENOUS INFUSION OF CLINDAMYCIN FOR THE TREATMENT OF OSTEOMYELITIS
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