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.
Approval to 1) extend the finished product uv absorbance specification from 0. 012 au to 0. 016 au and 2) eliminate the uv absorbance specification from the 24 month shelf-life.
| Device | AMO VITRAX (SODIUM HYALURONATE) VISCOELASTIC SOLUTION |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 1999-10-15 |
| Decision Date | 1999-11-08 |
| PMA | P880031 |
| Supplement | S013 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MEDICAL OPTICS INC 1700 E. St. Andrew Place santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880031 | Original Filing | |
| S016 | 2009-01-08 | Real-time Process |
| S015 | 2008-08-20 | 30-day Notice |
| S014 | 2007-02-15 | Normal 180 Day Track |
| S013 | 1999-10-15 | Real-time Process |
| S012 | 1998-02-02 | Real-time Process |
| S011 | 1995-12-26 | Normal 180 Day Track |
| S010 | 1995-11-24 | Normal 180 Day Track |
| S009 | 1995-10-17 | Normal 180 Day Track |
| S008 | 1994-06-02 | Special (immediate Track) |
| S007 | 1992-08-21 | Normal 180 Day Track |
| S006 | 1992-07-02 | Normal 180 Day Track |
| S005 | 1992-01-15 | Normal 180 Day Track |
| S004 | 1991-06-12 | Normal 180 Day Track |
| S003 | ||
| S002 | ||
| S001 |