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 | VASCULAR CATHETER |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S050 |
Date Received | 04/23/2002 |
Decision Date | 05/02/2002 |
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 CATHETER MODEL 8708 IN WHICH THE STRAIGHT CONNECTOR IS REPLACED WITH RIGHT ANGLE CONNECTOR, THE NUMBER OF ANCHOR BEADS IS INCREASED TO 12. ALSO, REMOVAL OF ACCESSORY COMPONENTS SPECIFIED AS GUIDE WIRE, TUNNELING ACCESSORIES AND TWO PRE-ATTACHED ANCHORS FROM MODEL 8700A, 8700V AND 8702 PACKAGE. THE DEVICE, AS MODIFIED, WILL BE MARKED UNDER THE TRADE NAME MEDTRONIC VASCULAR CATHETER MODEL 8708 AND IS INDICATED FOR USE WITH THE MEDTRONIC IMPLANTABLE INFUSION PUMPS TO PROVIDE FLUID PATHWAY. |
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