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.
Use of "pharmaceutical grade" sodium hyaluronate powder supplied by akzo nobel corporation, diosynth bv, kloosterstraat 6, 5349 ab oss, the netherlands, as an alternate supply of sodium hyaluronate powder for use in the manufacture of amo vitrax sodium hyaluronate
| Device | AMO VITRAX (SODIUM HYALURONATE) |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 1995-11-24 |
| Decision Date | 1996-04-08 |
| PMA | P880031 |
| Supplement | S010 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| 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 |