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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave, Suite 300A
Newton, MA 02459
PMA NumberP890055
Supplement NumberS033
Date Received01/28/2011
Decision Date05/23/2011
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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