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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 SERIES CONSTANT-FLOW IMPLANTABLE INFUSION PUMP, MEDSTREAM REFILL KITS, SURESTREAM INTRASPINAL CATHETER KIT,C
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave., Suite 300a
Newton, MA 02459
PMA NumberP890055
Supplement NumberS060
Date Received06/24/2015
Decision Date07/23/2015
Product Code LKK 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE VENDOR SUPPLIER THAT SUPPLIES THE TUBING FOR THE MEDSTREAM REFILL KIT AND MEDSTREAM BOLUS KIT AND A CHANGE IN THE FACILITY FOR MANUFACTURING OPERATIONS WITHIN THE SAME CAMPUS FOR THE VENDOR SUPPLIER THAT SUPPLIES THE TYVEK PACKAGING LIDS FOR THE CODMAN 3000 PUMP AND THE TYVEK RULERS FOR THE CODMAN INTRASPINAL CATHETER KITS.
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