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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 NameMODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
ApplicantCODMAN & SHURTLEFF, INC.
PMA NumberP890055
Supplement NumberS013
Date Received06/06/2001
Decision Date10/18/2002
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the indications for use to include glycerin injection as an infusate for use with patients who are receiving continuous hepatic arterial fudr chemotherapy with the arrow international model 3000 series of implantable infusion pumps to keep the catheter patent or to extend the refill interval for patients who require therapy or withdrawal.
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