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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.
 
DeviceMODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave., Suite 300a
Newton, MA 02459
PMA NumberP890055
Supplement NumberS016
Date Received07/16/2003
Decision Date08/12/2003
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: 1) REPLACE THE CURRENTLY APPROVED CATHETER KIT (AP-07002) WITH THE IP-36633 AND IP-3757 KITS, 2) REPLACE IP-36633 AND IP-3757 CONNECTOR WITH CODMAN 3000 (AP-07002) CONNECTOR, AND INCLUDE TITANIUM AS AN ALTERNATIVE CONNECTOR MATERIAL, 3) ADD ADDITIONAL COMPONENTS TO THE KIT AS A CONVENIENCE TO THE PHYSICIANS AND 4) LABELING CHANGE TO THE FLEXTIP PLUS INTRASPINAL CATHETER KIT INSTRUCTIONS FOR USE TO REFLECT THE CORRECT CATHETER VOLUME.
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