| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | ASCENSION MCP |
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| Generic Name | Finger semi-constrained pyrolytic carbon uncemented prosthesis |
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| Applicant | Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova, TN 38016 |
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| PMA Number | P000057 |
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| Date Received | 12/29/2000 |
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| Decision Date | 11/19/2001 |
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| Product Code |
NEG |
| Docket Number | 01M-0530 |
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| Notice Date | 11/29/2001 |
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| Advisory Committee |
Orthopedic |
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| Expedited Review Granted? | Yes |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
THIS DEVICE IS INDICATED FOR USE AS A TOTAL JOINT REPLACEMENT OF INDEX, LONG, RING, AND SMALL FINGER METACARPOPHALANGEAL JOINTS THAT EXHIBIT SYMPTOMS OF PAIN, LIMITED MOTION, OR INADEQUATE BONY ALIGNMENT (I.E., SUBLUXATION/DISLOCATION) SECONDRY TO ARTICULAR DESTRUCTION OR DEGENERATIVE DISEASE RELATED TO RHEUMATOID ARTHRITIS, LUPUS ERYTHEMATOSUS, OSTEOARTHRITIS, OR POST TRAUMATIC ARTHRITIS WHERE SOFT TISSUE RECONSTRUCTION CAN PROVIDE ADEQUATE STABILIZATION. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 |
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