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 | Ascension MCP |
Generic Name | Finger semi-constrained pyrolytic carbon uncemented prosthesis |
Applicant | Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
PMA Number | P000057 |
Supplement Number | S010 |
Date Received | 10/03/2017 |
Decision Date | 06/29/2018 |
Product Code |
NEG |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at Integra Life Sciences Corporation (Integra), 11101 Metric Boulevard, Austin, Texas. |
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