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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 NameINFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
Classification Namepump, infusion, implanted, programmable
Generic Nameimplanted infusion pump
ApplicantSTRATO/INFUSAID, INC.
PMA NumberP800036
Supplement NumberS015
Date Received09/16/1987
Decision Date09/20/1995
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for change in labeling to include epidural and intrathecal administration of infumorph 200 & 500 cii (preservative-free morphine) in patients suffering from severe and prolonged pain who are no longer responsive to conventional forms of analgesia.
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