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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.
 
DeviceSYNCHROMED II INFUSION SYSTEM
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS101
Date Received09/02/2008
Decision Date09/30/2008
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
CHANGE OF A MANUAL PROCESS TO AN AUTOMATED PROCESS, AND A CHANGE OF MANUFACTURING EQUIPMENT WHERE THE SPECIFICATIONS OF THE EQUIPMENT ARE UNCHANGED.
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