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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 MODEL 400 IMPLANTABLE INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Nameimplanted infusion pump
ApplicantCODMAN & SHURTLEFF, INC.
PMA NumberP800036
Supplement NumberS036
Date Received04/21/2006
Decision Date06/23/2006
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site at codman & shurtleff, inc. Raynham, massachusetts.
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