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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 3000/3000-16/3000-50 IMPLANTABLE
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pump
ApplicantTHEREX CORP.
PMA NumberP890055
Supplement NumberS010
Date Received05/11/1999
Decision Date05/27/1999
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
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.
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