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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameARROW INTERNATIONAL MODEL 3000-50 ML CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
Classification Namepump, infusion, implanted, programmable
Generic Namem3000-50 pump
ApplicantTHEREX CORP.
PMA NumberP890055
Supplement NumberS007
Date Received05/27/1998
Decision Date01/11/1999
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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