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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 II PROGRAMMABLE INFUSION PUMP
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS224
Date Received03/02/2015
Decision Date11/24/2015
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR TWO DESIGN CHANGES: 1) ENCAPSULATION OF MOTOR FEEDTHROUGHS WITH MEDICAL ADHESIVE IN ORDER TO REDUCE SYSTEM FAILURES FROM FEEDTHROUGH SHORTING; AND 2) THE ADDITION OF AN IMPEDANCE REQUIREMENT TO ENSURE ELECTRICAL ISOLATION OF THE MOTOR CIRCUIT.
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