| 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 MODELS 8780, 8781, 8782, 8784, 8785, 8786, AND 8787 |
|---|
| Generic Name | Pump, infusion, implanted, programmable |
|---|
| Applicant | MEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576 |
|---|
| PMA Number | P860004 |
|---|
| Supplement Number | S125 |
|---|
| Date Received | 04/19/2010 |
|---|
| Decision Date | 05/02/2012 |
|---|
| Product Code |
LKK |
| Advisory Committee |
General Hospital |
|---|
| Supplement Type | Normal 180 Day Track |
|---|
| Supplement Reason | Change Design/Components/Specifications/Material |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Recalls | CDRH Recalls |
|---|
Approval Order Statement
APPROVAL FOR THE SUBJECT ASCENDA CATHETER, WHICHCONSIST OF TWO MODELS (8780 AND 8781) (HAT ARE IDENTICAL IN COMPONENTS AND ACCESSORIES AND DIFFER ONLY IN THEIR TOTAL LENGTH. THIS CATHETER DIFFERS FROM THE CURRENT INTRATHECAL CATHETERS USED WITH MEDTRONIC IMPLANTABLE PUMPS BY THE FOLLOWING MODIFICATIONS: 1) MULTI-LAYERED CATHETER BODY THAT RESISTS CUTS, FRACTURES, AND OCCLUSIONS; 2) BI-WING ANCHOR WITH NEW ANCHOR DISPENSER DESIGNED TO PREVENT CATHETER DISLODGMENT; 3) CATHETER CONNECTOR THAT PREVENTS PUNCTURE OF THE CATHETER BODY; AND 4) MODIFIED SUTURELESS PUMP CONNECTOR DESIGN TO PREVENT OCCLUSION. |
|
|
