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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 NumberS033
Date Received02/03/2011
Decision Date05/23/2011
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software modification to the medstream programmable infusion system. The modified medstream pump will have software ps-100044 version 3. 06, the modified control unit will have software ps-100046 version 3. 00. Ps-100045 version 3. 04, ps-1000047 version 3. 09 and ps-100021 version 2. 00. 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. 0ph) in the treatment of severe spasticity.
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