Premarket Approval (PMA)

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.

• Device: ASCENDA INTRATHECAL CATHETERS AND KITS
• Generic Name: pump, infusion, implanted, programmable
• Applicant: MEDTRONIC Inc.; 7000 central avenue ne; minneapolis, MN 55432-3576
• PMA Number: P860004
• Supplement Number: S257
• Date Received: 06/30/2016
• Decision Date: 09/27/2016
• Product Code: LKK
• Advisory Committee: General Hospital
• Supplement Type: real-time process
• Supplement Reason: labeling change - indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes

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.