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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.
 
DeviceCodman 3000 Series Constant-Flow Implantable Infusion Pump and MedStream Implantable Infusion Pump
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave., Suite 300a
Newton, MA 02459
PMA NumberP890055
Supplement NumberS064
Date Received08/02/2016
Decision Date08/29/2016
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications associated with accessories for P800036 and P890055: Needles: needle drawing changes and process control improvements at the supplier; and Luer adaptor: supplier manufacturing site changes.
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