|
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. |