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 CATHETER WITH 86 CM SPINAL SEGMENT, 66CM SPINAL SEGMENT, 86 CM SPINAL SEGMENT REVISION KIT, ACCESSOR |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S250 |
Date Received | 05/31/2016 |
Decision Date | 09/09/2016 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
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. |
|
|