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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 PUMP SILICONE CATHETER
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave., Suite 300a
Newton, MA 02459
PMA NumberP890055
Supplement NumberS019
Date Received09/28/2006
Decision Date10/19/2006
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO CHANGE THE MATERIAL OF THE THREE SILICONE BEADS ATTACHED TO THE DISTAL END OF THE PUMP CATHETER DURING MANUFACTURE TO A DIFFERENT SILICONE, NUSIL MED-4850 (SSF-MLTN-850 45-55).
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