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Trade Name | ASCENSION PIP |
Classification Name | finger semi-constrained pyrolytic carbon uncemented prosthesis |
Generic Name | finger semi-constrained pyrolytic carbon uncemented prosthesis |
Applicant |
Smith & Nephew, Inc. |
7135 goodlett farms parkway |
cordova, TN 38016 |
|
HDE Number | H010005 |
Supplement Number | S003 |
Date Received | 07/03/2003 |
Decision Date | 08/11/2003 |
Product Code | |
Docket Number | 02M-0121 |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
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. |