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 Refill Kit |
Generic Name | pump, infusion, implanted, programmable |
Applicant | Intera Oncology 65 william street suite 200 wellesley, MA 02481 |
PMA Number | P890055 |
Supplement Number | S067 |
Date Received | 05/16/2017 |
Decision Date | 08/14/2017 |
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 a material change to components of the Cadman 3000 Refill Kit. |
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