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.
| Device | ASCENSION MCP FINGER IMPLANT |
| Classification Name | Finger Semi-constrained Pyrolytic Carbon Uncemented Prosthesis |
| Generic Name | Finger Semi-constrained Pyrolytic Carbon Uncemented Prosthesis |
| Applicant | INTEGRA LIFESCIENCES CORPORATION |
| Date Received | 2014-10-01 |
| Decision Date | 2018-09-10 |
| PMA | P000057 |
| Supplement | S008 |
| Product Code | NEG |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INTEGRA LIFESCIENCES CORPORATION 8900 Cameron Road austin, TX 78754 |
| 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 |