Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device. |
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Trade Name | Ascension PIP |
Classification Name | high demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis |
Generic Name | high demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis |
Applicant |
Smith & Nephew, Inc. |
7135 goodlett farms parkway |
cordova, TN 38016 |
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HDE Number | H010005 |
Supplement Number | S010 |
Date Received | 01/05/2024 |
Decision Date | 03/20/2024 |
Product Code | |
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 add mr conditional labeling. |
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