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 | S002 |
Date Received | 07/02/2003 |
Decision Date | 08/11/2003 |
Product Code |
NEG |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO EXTEND THE SHELF LIFE EXPIRATION DATE FROM 2 YEARS TO 4 YEARS. |
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