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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Date Received02/03/1986
Decision Date03/14/1988
Product Code LKK 
Docket Number 88M-0114
Notice Date 05/11/1988
Advisory Committee General Hospital
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Medtronic® SynchroMed™ Infusion System. This device is indicated for chronic intravascular infusion of floxuridine (FUDR) or doxorubicin hydrochloride (Adriamycin) and, when required bacteriostatic water, physiological saline and/or heparin.
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