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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 St.
Suite 2000
Wellesley, MA 02481
PMA NumberP800036
Supplement NumberS039
Date Received08/02/2016
Decision Date08/29/2016
Withdrawal Date03/12/2021
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
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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