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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.
 
DeviceINFUSAID Implantable Infusion Pump and Accessories
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
65 William St.
Suite 2000
Wellesley, MA 02481
PMA NumberP800036
Supplement NumberS041
Date Received01/09/2020
Decision Date02/07/2020
Withdrawal Date03/12/2021
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 ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Intera Oncology, Inc., 65 William Street, Suite 200, Wellesley, Massachusetts, to conduct quality system activities.
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