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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 INFUSION PUMPS
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pump
ApplicantTHEREX CORP.
PMA NumberP890055
Supplement NumberS011
Date Received10/12/1999
Decision Date10/25/1999
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason design change - minor
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.
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