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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 NumberS023
Date Received10/23/2007
Decision Date11/26/2007
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 FOR THE FOLLOWING CHANGES TO THE FLEXTIP PLUS INTRASPINAL CATHETER KIT AND TO THE CODMAN 3000 PUMP ACCESSORIES: 1) REPLACE 3 MM-BEVELED TUOHY NEEDLE WITH A 4 MM-BEVELED TUOHY NEEDLE; 2) REMOVE A RULER; 3) REPLACE REMAINING RULER WITH A NEW RULER; 4) REDUCE AERATION TIME FOR CODMAN 3000 PUMP ACCESSORIES; 5) NEW PACKAGING DESIGN; 6) NEW PACKAGING MATERIALS; 7) UPDATE LABELING TO REFLECT COMPONENT CHANGES; AND 8) CLARIFY ADDITIONAL NON-PYROGENIC COMPONENTS AND PROCEDURAL STEPS.
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