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.
Changes to the process for use of the burst test fixture, which is used to evaluate the seal strength of the packaging.
| Device | EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | EXACTECH, INC. |
| Date Received | 2012-07-24 |
| Decision Date | 2012-08-24 |
| PMA | P050039 |
| Supplement | S010 |
| Product Code | MRA |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EXACTECH, INC. 2320 N.w. 66th Ct. gainesville, FL 32653 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050039 | Original Filing | |
| S021 | 2016-09-01 | Normal 180 Day Track No User Fee |
| S020 | 2016-09-01 | 30-day Notice |
| S019 | 2016-06-24 | 30-day Notice |
| S018 | 2015-12-09 | 30-day Notice |
| S017 | 2015-07-06 | Normal 180 Day Track No User Fee |
| S016 | 2014-05-20 | 30-day Notice |
| S015 | 2013-01-11 | 30-day Notice |
| S014 | 2012-11-14 | 30-day Notice |
| S013 | 2012-10-04 | 30-day Notice |
| S012 | 2012-09-18 | 30-day Notice |
| S011 | 2012-08-30 | 30-day Notice |
| S010 | 2012-07-24 | 30-day Notice |
| S009 | 2012-03-28 | Special (immediate Track) |
| S008 | 2012-03-26 | 135 Review Track For 30-day Notice |
| S007 | 2011-10-07 | 135 Review Track For 30-day Notice |
| S006 | ||
| S005 | 2011-03-11 | Special (immediate Track) |
| S004 | 2009-09-15 | Normal 180 Day Track No User Fee |
| S003 | 2009-08-19 | 30-day Notice |
| S002 | 2008-07-31 | 135 Review Track For 30-day Notice |
| S001 | 2007-10-31 | Normal 180 Day Track No User Fee |