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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 Pump Control Unit
Generic Namepump, infusion, implanted, programmable
ApplicantIntera Oncology
65 william street
suite 200
wellesley, MA 02481
PMA NumberP890055
Supplement NumberS070
Date Received09/22/2017
Decision Date10/16/2017
Product Code LKK 
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Transfer of the downstream manufacturing processes for the MedStream Control Unit from the Medos Sarl facility to the Medos International facility.