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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 MODELS 8616-10 & 8617-10(ALSO REFERRED TO AS MODELS 8631 & 8635) SYNCHROMED(R) IMPLANT.PROGRAM. INFUSION PUMP
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS022
Date Received09/13/1991
Decision Date07/29/1996
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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