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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
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS175
Date Received11/13/2012
Decision Date01/07/2013
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a minor design control change, and subsequent manufacturing process changes, to remove the lack of lamination note from the pump and spinal catheter segments assembly level prints for the device.
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