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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.
 
DeviceMODEL 855 REFILL KIT
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS163
Date Received11/07/2011
Decision Date04/27/2012
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT SURGICAL TECHNOLOGIES, INC. IN SAINT PAUL, MINNESOTA.
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