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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-100,200,4
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
65 William Street
Suite 2000
Wellesley, MA 02481
PMA NumberP800036
Supplement NumberS013
Date Received12/10/1985
Decision Date11/04/1988
Withdrawal Date 03/12/2021
Product Code LKK 
Docket Number 82M-0072
Notice Date 02/01/1989
Advisory Committee General Hospital
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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