|
Device | MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 180 Wells Ave, Suite 300A Newton, MA 02459 |
PMA Number | P890055 |
Supplement Number | S013 |
Date Received | 06/06/2001 |
Decision Date | 10/18/2002 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INDICATIONS FOR USE TO INCLUDE GLYCERIN INJECTION AS AN INFUSATE FOR USE WITH PATIENTS WHO ARE RECEIVING CONTINUOUS HEPATIC ARTERIAL FUDR CHEMOTHERAPY WITH THE ARROW INTERNATIONAL MODEL 3000 SERIES OF IMPLANTABLE INFUSION PUMPS TO KEEP THE CATHETER PATENT OR TO EXTEND THE REFILL INTERVAL FOR PATIENTS WHO REQUIRE THERAPY OR WITHDRAWAL. |