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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 MODEL 400 IMPLANTABLE INFUSION PUMP
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
65 William Street
Suite 2000
Wellesley, MA 02481
PMA NumberP800036
Supplement NumberS036
Date Received04/21/2006
Decision Date06/23/2006
Withdrawal Date 03/12/2021
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE AT CODMAN & SHURTLEFF, INC.RAYNHAM, MASSACHUSETTS.
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