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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 System
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave., Suite 300a
Newton, MA 02459
PMA NumberP890055
Supplement NumberS075
Date Received06/11/2020
Decision Date01/22/2021
Product Code LKK 
Advisory Committee General Hospital
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for requested replacement of the sealing machine used at Intera Oncology, Inc. (Intera) subcontractor to seal the lid of the syringe barrel, which is a component included in the refill kits approved as accessories for the implanted infusion pumps.
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