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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 NumberS030
Date Received01/18/2011
Decision Date03/15/2011
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL PROTOCOL.
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