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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 NameARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pump
ApplicantTHEREX CORP.
PMA NumberP890055
Supplement NumberS006
Date Received09/30/1997
Decision Date09/15/1998
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of lioresal intrathecal (baclofen injection) to the list of drugs approved for use with the m-3000 implantable drug delivery pump with bolus safety valve.
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