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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 NameCONSTANT FLOW IMPLANTABLE INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pump
ApplicantTHEREX CORP.
PMA NumberP890055
Supplement NumberS009
Date Received02/23/1999
Decision Date01/21/2000
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
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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