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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.
 
DeviceIntera Hepatic Artery Infusion Pump
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave., Suite 300a
Newton, MA 02459
PMA NumberP890055
Supplement NumberS074
Date Received06/01/2020
Decision Date06/22/2021
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Proven Process Medical Devices, 110 Forbes Road, Mansfield, Massachusetts 02048 which will perform manufacturing of the Intera 3000 Hepatic Artery Infusion Pump (Intera 3000, 30mL high flow rate)
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