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 | CODMAN 3000 PUMP SILICONE CATHETER |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | Intera Oncology 180 Wells Ave, Suite 300A Newton, MA 02459 |
PMA Number | P890055 |
Supplement Number | S019 |
Date Received | 09/28/2006 |
Decision Date | 10/19/2006 |
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 TO CHANGE THE MATERIAL OF THE THREE SILICONE BEADS ATTACHED TO THE DISTAL END OF THE PUMP CATHETER DURING MANUFACTURE TO A DIFFERENT SILICONE, NUSIL MED-4850 (SSF-MLTN-850 45-55). |
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