| 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. |
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| Trade Name | MEDTRONIC SYNCHROMED INFUSION SYSTEM |
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| Classification Name | pump, infusion, implanted, programmable |
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| Generic Name | implanted infusion pump |
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| Applicant | MEDTRONIC VASCULAR |
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| PMA Number | P860004 |
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| Supplement Number | S035 |
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| Date Received | 05/08/1996 |
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| Decision Date | 09/10/1996 |
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| Product Code | |
| Advisory Committee |
General Hospital |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | labeling change - indications |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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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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