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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
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS035
Date Received05/08/1996
Decision Date09/10/1996
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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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