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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.
 
DeviceCONSTANT FLOW IMPLANTABLE INFUSION PUMP
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave., Suite 300a
Newton, MA 02459
PMA NumberP890055
Supplement NumberS009
Date Received02/23/1999
Decision Date01/21/2000
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for adding the Drug Lioresal (Baclofen) to the list of drugs approved for use with the Model 3000-16 and Model 3000-50 Implantable Drug Delivery Pumps. Also, the label will clearly indicate that baclofen is stable for 44 days at 37C.
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