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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 NameASCENDA INTRATHECAL CATHETER MODELS 8780, 8781, 8782, 8784, 8785, 8786, AND 8787
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS125
Date Received04/19/2010
Decision Date05/02/2012
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 No
Approval Order Statement 
Approval for the subject ascenda catheter, which consist of two models (8780 and 8781) (hat are identical in components and accessories and differ only in their total length. This catheter differs from the current intrathecal catheters used with medtronic implantable pumps by the following modifications: 1) multi-layered catheter body that resists cuts, fractures, and occlusions; 2) bi-wing anchor with new anchor dispenser designed to prevent catheter dislodgment; 3) catheter connector that prevents puncture of the catheter body; and 4) modified sutureless pump connector design to prevent occlusion.
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