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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 & ISOMED DRUG INFUSION SYSTEMS
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS114
Date Received10/01/2009
Decision Date10/30/2009
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 changes to the implant manuals for the following sutureless connector catheters: model 8709sc indura 1p one-piece intrathecal catheter with sutureless connector, model 8731sc intrathecal catheter with sutureless connector, model 8578 sutureless pump connector revision kit, and model 8696sc intrathecal catheter pump segment revision kit with sutureless connector.
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