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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
ApplicantCODMAN & SHURTLEFF, INC.
PMA NumberP800036
Supplement NumberS035
Date Received10/21/1997
Decision Date12/19/1997
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for packaging and sterilizing the arrow 22 gauge non-coring needle inside the strato/infusaid refill kit (#103381) in addition to the individually packaged sterile needle configuration.
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