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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
Classification Namepump, infusion, implanted, programmable
Generic Nameimplanted infusion pump
ApplicantINFUSAID CORP.
PMA NumberP800036
Supplement NumberS031
Date Received03/08/1994
Decision Date12/23/1996
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the unfusaid(tm) 14g intraspinal catheter kit, an accessory to the infusaid implantable infusion pump.
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