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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.
 
Trade NameMEDTRONIC MODELS 8616-10 & 8617-10(ALSO REFERRED TO AS MODELS 8631 & 8635) SYNCHROMED(R) IMPLANT.PROGRAM. INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Nameimplanted infusion pump
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS022
Date Received09/13/1991
Decision Date07/29/1996
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for (1) the 10 cc synchromed implantable programmable infusion pump, models 8616-10 and 8617-10 for use in the pediatric and adult population for the intrathecal delivery of lioresal intrathecal (baclofen injection( for the management of severe spasticity of spinal and cerebral origin, and (2) to change the indications for the intrathecal delivery of lioresal intrathecal (baclofen injection) for the 18 cc reservoir synchromed implantable, programmable infusion pumps, models 8616-18, 8617-18, 8617l-18, 8618-18, and 8618l-18 to include severe spasticity of cerebral origin.
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