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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.
 
Trade NameSYNCHROMED II INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS100
Date Received08/04/2008
Decision Date09/03/2008
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for labeling changes for intrathecal catheter models 8709sc, 8731sc, 8578 and 8596sc.
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