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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.
 
DeviceFLEX TIP INTRASPINAL KIT, CATALOG AP-07008
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave., Suite 300a
Newton, MA 02459
PMA NumberP890055
Supplement NumberS005
Date Received09/09/1997
Decision Date12/23/1998
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Flex tip Plus Intraspinal Catheter Kit, Catalog AP-07008. This Catheter Kit will be used with the model 3000 Implantable Pump with Bolus Safety Valve for intraspinal delivery of preservative free morphine to patients with chronic intractable pain.
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