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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceASCENDA INTRATHECAL CATHETER WITH 86 CM SPINAL SEGMENT, 66CM SPINAL SEGMENT, 86 CM SPINAL SEGMENT REVISION KIT, ACCESSOR
Generic Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS250
Date Received05/31/2016
Decision Date09/09/2016
Product Code LKK 
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the addition of a low-PFOA (perfluorooctanoic acid) polytetrafluoroethylene (PTFE) coating to the Anchor Dispenser Tool (ADT) to address customer complaints of difficulty deploying the Ascenda anchor from the Anchor Dispenser Tool; the addition of the flare to the hypotube; the updated materials list in the Ascenda Implant Manual and minor changes to dimension tolerances on the Anchor Dispenser Tool.
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