|
Device | ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 180 Wells Ave, Suite 300A Newton, MA 02459 |
PMA Number | P890055 |
Supplement Number | S010 |
Date Received | 05/11/1999 |
Decision Date | 05/27/1999 |
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 to the device: 1)Replacement of the standard 50 ml syring with a calibrated syringe in the refill kit and related labeling; 2) the incorporation of a special bolus winged infusion set; 3) Increase the volume of water placed into the pump reservoir prior to sterilization; 4) Revise the labeling to refer the user to the instruction for use of the device. |