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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 SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS239
Date Received10/06/2015
Decision Date11/04/2015
Product Code LKK 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL TO RELOCATE THE SUPPLIER MANUFACTURING FACILITY FOR THE ROTOR ASSEMBLY AND THE FINISHED MOTOR COMPONENT OF THE SYNCHROMED II MOTOR APPROVED UNDER P860004/S217 AS WELL AS REPLACE EXISTING EQUIPMENT (LASER MARKING EQUIPMENT AND TOOL MAKER'S MICROSCOPE) IN THE MOTOR MANUFACTURING PROCESS.
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