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.
Change from performing fluorescent penetrant inspection (fpi) at qc labs to performing the inspection step in-house as well as a process change at ceramtec.
| Device | EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM |
| Classification Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented |
| Applicant | EXACTECH, INC. |
| Date Received | 2009-08-19 |
| Decision Date | 2009-09-30 |
| PMA | P050039 |
| Supplement | S003 |
| 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 |