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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 3000 Hepatic Artery Infusion Pump
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave, Suite 300A
Newton, MA 02459
PMA NumberP890055
Supplement NumberS082
Date Received07/29/2022
Decision Date10/28/2022
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for an added inspection of the capillary crimps and tightening of the capillary leakage acceptance criterion.
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