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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 NameMEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
ApplicantCODMAN & SHURTLEFF, INC.
PMA NumberP890055
Supplement NumberS032
Date Received03/11/2011
Decision Date05/10/2011
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new adhesive to secure the antenna and modification to the piezo actuator release specification. The device, as modified, will be marketed under the trade name medstream programmable infusion system and is indicated for the chronic intrathecal infusion of baclofen injection sterile solution (5. 0 ph to 7. 0 ph) in the treatment of severe spasticity.
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