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 change the ph product specification range for healon d from 7. 1 ¿ 7. 5 to 6. 8 ¿ 7. 6.
| Device | HEALON D SODIUM HYALURONATE SOLUTION |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 2009-01-08 |
| Decision Date | 2009-02-18 |
| PMA | P880031 |
| Supplement | S016 |
| 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 |