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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceSYNCHROMED II IMPLANTABLE INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS108
Date Received07/02/2009
Decision Date09/04/2009
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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