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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.
 
DeviceCODMAN 3000 IMPLANTABLE INFUSION PUMP
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave., Suite 300a
Newton, MA 02459
PMA NumberP890055
Supplement NumberS020
Date Received08/06/2007
Decision Date08/23/2007
Product Code LKK 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE 1) IN PACKAGING LOCATION FOR THE BARBED CATHETER CONNECTOR TO AN IN-HOUSE PROCEDURE AT CODMAN & SHURTLEFF, RAYNHAM, MASSACHUSETTS FROM AVID MEDICAL, ROANO, VIRGINIA, AND 2) CHANGE IN THE BARBED CATHETER CONNECTOR PACKAGING TO THE APPROVED PACKAGING FOR THE FLEX 1 REPLACEMENT CONNECTOR.
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