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.
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.
| Device | ASCENSION MCP |
| Classification Name | Finger Semi-constrained Pyrolytic Carbon Uncemented Prosthesis |
| Generic Name | Finger Semi-constrained Pyrolytic Carbon Uncemented Prosthesis |
| Applicant | INTEGRA LIFESCIENCES CORPORATION |
| Date Received | 2000-12-29 |
| Decision Date | 2001-11-19 |
| Notice Date | 2001-11-29 |
| PMA | P000057 |
| Supplement | S |
| Product Code | NEG |
| Docket Number | 01M-0530 |
| Advisory Committee | Orthopedic |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | INTEGRA LIFESCIENCES CORPORATION 8900 Cameron Road austin, TX 78754 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000057 | Original Filing | |
| S011 | 2018-10-10 | Normal 180 Day Track No User Fee |
| S010 | 2017-10-03 | Normal 180 Day Track No User Fee |
| S009 | 2016-06-21 | Real-time Process |
| S008 | 2014-10-01 | Normal 180 Day Track No User Fee |
| S007 | 2013-09-10 | Real-time Process |
| S006 | 2010-04-07 | 135 Review Track For 30-day Notice |
| S005 | 2009-10-05 | Normal 180 Day Track No User Fee |
| S004 | 2008-02-19 | Real-time Process |
| S003 | 2006-02-06 | Normal 180 Day Track |
| S002 | 2003-07-02 | Real-time Process |
| S001 | 2001-12-19 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| M269MCP10050PWW1 | P000057 | 007 |
| 00885556856802 | P000057 | 007 |
| 00885556856789 | P000057 | 007 |
| 00885556856765 | P000057 | 007 |
| 00885556856741 | P000057 | 007 |
| 00885556856727 | P000057 | 007 |
| 00885556856819 | P000057 | 007 |
| 00885556856796 | P000057 | 007 |
| 00885556856772 | P000057 | 007 |
| 00885556856758 | P000057 | 007 |
| 00885556856734 | P000057 | 007 |
| 00885556856826 | P000057 | 007 |
| M269MCP11005DWW1 | P000057 | 007 |
| M269MCP10050DWW1 | P000057 | 007 |
| M269MCP10040PWW1 | P000057 | 007 |
| M269MCP10040DWW1 | P000057 | 007 |
| M269MCP10030PWW1 | P000057 | 007 |
| M269MCP10030DWW1 | P000057 | 007 |
| M269MCP10020PWW1 | P000057 | 007 |
| M269MCP10020DWW1 | P000057 | 007 |
| M269MCP10010PWW1 | P000057 | 007 |
| M269MCP10010DWW1 | P000057 | 007 |
| M269MCP11005PWW1 | P000057 | 007 |
| 00885556856710 | P000057 | 007 |