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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 NameSYNCHROMED2 PUMP FEED-THROUGHS & CATHETER ACCESSORIES
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS128
Date Received05/06/2010
Decision Date12/03/2010
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for modifications to the introducer needle tip, needle hub, and stylet cap materials for the introducer needle used with the models 8709, 8709sc, 8711 and 8731sc intrathecal catheters and model 8598a revision kit.
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