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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.
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
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.