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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.
 
DeviceCodman 3000 Refill Kit
Generic Namepump, infusion, implanted, programmable
ApplicantIntera Oncology
65 william street
suite 200
wellesley, MA 02481
PMA NumberP890055
Supplement NumberS067
Date Received05/16/2017
Decision Date08/14/2017
Product Code LKK 
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a material change to components of the Cadman 3000 Refill Kit.
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