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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 MODEL 400
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
65 William Street
Suite 2000
Wellesley, MA 02481
PMA NumberP800036
Supplement NumberS029
Date Received05/18/1992
Decision Date06/17/1993
Withdrawal Date 03/12/2021
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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