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 | S003 |
Date Received | 02/06/2006 |
Decision Date | 07/17/2006 |
Product Code |
NEG |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD A SIZE 05 IMPLANT TO THE PRODUCT LINE. |
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