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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.
 
DeviceFLEXTIP PLUS INTRASPINAL CATHETER KIT
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave, Suite 300A
Newton, MA 02459
PMA NumberP890055
Supplement NumberS024
Date Received11/19/2007
Decision Date12/18/2007
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
Approval Order Statement  
CHANGE TO: 1) THE PACKAGING LOCATION FROM AVID MEDICAL TO CODMAN & SHURTLEFF, INC.; 2) THE PACKAGING COMPONENT SUPPLIERS; AND 3) THE TOUHY NEEDLES AND RULER SUPPLIERS.
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