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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 IMPLANTABLE INFUSION PUMP
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave. NE
Minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS042
Date Received02/26/1999
Decision Date03/18/1999
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for addition of an alternate catheter port for use with the SynchroMed pump, Model 8508 CAP; Addition of an Application Specific Integrated Circuit (ASIC) buffer chip to the pumps hybrid to improve battery longevity; addition of another suture loop to the shield; change in the device name from SynchroMed(TM) to SynchroMed EL(TM); change in model numbers (new model numbers represent new SynchroMed EL Pumps); and change to labeling.
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