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. |
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Device | MODEL 3000 SERIES IMPLANTABLE INFUSION PUMPS |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 180 Wells Ave, Suite 300A Newton, MA 02459 |
PMA Number | P890055 |
Supplement Number | S016 |
Date Received | 07/16/2003 |
Decision Date | 08/12/2003 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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