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.
New sterilization site at griffith micro science in glen falls, new york and a new sterilization process, 100% ethylene oxide, for amo vitrax (sodium hyaluronate) in final packaging
| Device | AMO(R) VITRAX(R) VISCOELASTIC SOLUTION |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 1995-10-17 |
| Decision Date | 1996-04-09 |
| PMA | P880031 |
| Supplement | S009 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |