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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceARROW INTERNATIONAL MODEL 3000-50 ML CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave, Suite 300A
Newton, MA 02459
PMA NumberP890055
Supplement NumberS007
Date Received05/27/1998
Decision Date01/11/1999
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Arrow Model 3000-50 Constant Flow Implantable Pump for adults for the following indications: 1)the intraspinal delivery of preservative free morphine for patient with intractable chronic pain, 2) the intraspinal deliery of preservative free morphine for the treatment of pain ofmalignant origin, and 3) the continuous regional intra-arterial delivery of 2'-deoxy-5fluorouridine (FUDR), heparinized saline, normal saline, and bacteriostatic water.
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