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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 3000/3000-16/3000-50 IMPLANTABLE INFUSION PUMPS
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
CODMAN
325 paramount dr.
raynham, MA 02767
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 change design/components/specifications/material
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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