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Device | ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 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 | S011 |
Date Received | 10/12/1999 |
Decision Date | 10/25/1999 |
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 following modifications: 1) Increasing the Flex Tip Plus Intraspinal Catheter length; 2) Combining the infusion pump and the approved refill kit to facilitate the pump pre-implant procedure; 3) Adding a thermometer to the packaging for the monitoring of water bath temperature; and 4) Adding an informational chart of drug solution to the labeling. |