This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | ALCON LABORATORIES |
| Date Received | 1999-05-07 |
| Decision Date | 2000-02-24 |
| Notice Date | 2000-08-03 |
| PMA | P990023 |
| Supplement | S |
| Product Code | LZP |
| Docket Number | 00M-0809 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALCON LABORATORIES 6201 South Freeway fort Worth, TX 76134 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990023 | Original Filing | |
| S018 | 2022-08-24 | 30-day Notice |
| S017 | 2022-08-23 | 30-day Notice |
| S016 | 2016-06-17 | Normal 180 Day Track |
| S015 | 2016-04-28 | Real-time Process |
| S014 | 2016-04-25 | 30-day Notice |
| S013 | 2015-04-23 | Normal 180 Day Track |
| S012 | 2014-01-31 | 30-day Notice |
| S011 | 2011-04-19 | 30-day Notice |
| S010 | 2010-10-15 | 30-day Notice |
| S009 | 2010-05-24 | 30-day Notice |
| S008 | 2009-09-15 | 30-day Notice |
| S007 | 2009-08-04 | 30-day Notice |
| S006 | 2008-11-24 | 30-day Notice |
| S005 | 2008-10-31 | 30-day Notice |
| S004 | 2008-04-08 | 30-day Notice |
| S003 | 2004-05-14 | Special (immediate Track) |
| S002 | 2003-10-24 | Special (immediate Track) |
| S001 | 2000-04-24 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00380651838109 | P990023 | 000 |