Approval for labeling changes to the package insert, surgical technique, patient information brochure, and post-operative therapy brochure
| 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 | 2018-10-10 |
| Decision Date | 2019-03-05 |
| PMA | P000057 |
| Supplement | S011 |
| Product Code | NEG |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | INTEGRA LIFESCIENCES CORPORATION 8900 Cameron Road austin, TX 78754 |
Supplemental Filings
| 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 |
NIH GUDID Devices