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. |
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Device | MEDTRONIC MODEL 8749 INTRATHECAL CATHETER |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S057 |
Date Received | 11/03/2003 |
Decision Date | 11/18/2003 |
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 | No |
Approval Order Statement APPROVAL FOR THE CHANGES TO THE MODEL 8731 INTRATHECAL CATHETER TO INCLUDE 1) A CHANGE TO THE LENGTH OF PROXIMAL AND DISTAL SEGMENTS OF THE CATHETER; 2) A CHANGE TO THE TUBING CONNECTOR, 3) REVISIONS TO MODEL 8596 AND MODEL 8749 REVISION KITS, 4) REVISIONS TO THE CATHETER TUBING SPECIFICATIONS; AND 5) ADDITION OF A CRIMP SLEEVE TO THE GUIDE WIRE. |
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