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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceSYNCHROMED INFUSION SYSTEMS, SYNCHROMED, SYNCHROMED II, SYNCHROMED EL
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS177
Date Received10/05/2012
Decision Date12/17/2012
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 MINOR CHANGES TO MODEL 8840 N'VISION PROGRAMMERSOFTWARE FOR END OF SERVICE AND LOW/EMPTY RESERVOIR ALARMS AND IS INDICATED FOR USE WITH SYNCHROMED EL AND SYNCHROMED II PUMPS.
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