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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 NameM3000 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pump
ApplicantTHEREX CORP.
PMA NumberP890055
Supplement NumberS001
Date Received06/05/1996
Decision Date06/27/1996
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the "model 3000 medication calculator" to the labeling for the m3000 constant flow implantable pump with bolus safety valve.
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