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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.
DeviceModel 400 Implantable Infusion Pump
Generic Namepump, infusion, implanted, programmable
ApplicantIntera Oncology
65 william street
suite 2000
wellesley, MA 02481
PMA NumberP800036
Supplement NumberS040
Date Received06/08/2017
Decision Date07/05/2017
Withdrawal Date 03/12/2021
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  
Implementation of a new sterilization chamber control system at the sterilization facility to replace the current system.