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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 NameCODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
ApplicantCODMAN & SHURTLEFF, INC.
PMA NumberP890055
Supplement NumberS026
Date Received12/11/2007
Decision Date12/17/2010
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for medstream programmable infusion system. The device, as modified, will be marketed under the trade name medstream programmable infusion system and is indicated for chronic intrathecal infusion of baclofen injection sterile solution (5. 0 ph to 7. 0 ph) in the treatment of severe spasticity.
Post-Approval StudyShow Report Schedule and Study Progress
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