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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 PUMP WITH BOLUS SAFETY VALVE
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pump
ApplicantTHEREX CORP.
PMA NumberP890055
Supplement NumberS003
Date Received02/26/1997
Decision Date09/22/1997
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 intraspinal delivery of preservative free morphine for patient with intractable chronic pain.
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