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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.
Generic Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS257
Date Received06/30/2016
Decision Date09/27/2016
Product Code LKK 
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for labeling changes for Medtronics Ascenda Intrathecal Catheter and Revision Kit including: Implant Manuals Catheter Length Measurement; Implant Manuals Materials Table; Implant Manuals Verb change; Implant Manuals Reference to Model 8784 Kit added; Implant Manuals Other clarification, administrative and style changes; Package Labels Catheter Length Measurements; Package Labels Addition of symbols; Package Labels Other minor changes. These changes impact the manuals associated with the following models: Full Catheter Kit 8780 Ascenda Intrathecal Catheter (86cm spinal segment); Full Catheter Kit 8781 Ascenda Intrathecal Catheter (66cm spinal segment); Revision Catheter Kit 8782 Ascenda Intrathecal Catheter (86cm spinal segment revision kit); Revision Catheter Kit 8784 Ascenda Intrathecal Catheter (74cm spinal segment revision kit); Revision Catheter Kit 8785 Ascenda Accessory Kit. These changes impact the packaging labels associated with the following labels: Model 8780 Implant Manual; Model 8781 Implant Manual; Model 8782 Implant Manual; Model 8784 Implant Manual; Model 8780 Package Label; Model 8781 Package Label; Model 8782 Package Label; Model 8784 Package Label; Model 8785 Package Label.