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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 IMPLANTABLE INFUSION SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS108
Date Received07/02/2009
Decision Date09/04/2009
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
Approval Order Statement  
APPROVAL FOR: 1) UPDATED MANUALS WITH THE GENERAL TERM "PLASTIC" TO DESCRIBE THE NEW HUB/CAP MATERIAL AND ADDED OTHER MINOR CLARIFICATIONS;2) ADDED COMPARTMENT TO FORM AN INNER TRAY TO CONTAIN ACCESSORIES - ELIMINATES BAGGING AND REDUCES MANUFACTURING COST;3) INNER TRAY IS PLACED IN AN OUTER TRAY AND SEALED WITH A POLYETHYLENE LID;4) INNER TRAY, INNER LID AND OUTER TRAY MATERIAL CHANGED TO POLYETHYLENE TEREPHTHALATE (PET)FOR IMPROVED RECYCLING; AND5) MODIFIED BOX TO ACCOMMODATE NEW TRAY DESIGN AND ADDITIONAL (EUROPEAN) LANGUAGES INMANUALS.
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