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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 NumberS040
Date Received05/14/2012
Decision Date06/25/2012
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR SOFTWARE MODIFICATIONS TO THE PROGRAMMABLE INFUSION SYSTEM. THESE MODIFICATIONS WERE DATA INTEGRITY CHECK IMPROVEMENT, RESOLUTION OF CONTROL UNIT KEYBOARD, FRAME CHECK SEQUENCE ALGORITHM UPGRADE, SOFTWARE ANOMALIES 015, 016, 017, 020 FIX, AND IMPROVEMENT OF THE BRIDGE BOLUS, PRIMING BOLUS AND SINGLE BOLUS PROCESSES.
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