Approval for adding the precaution, "use only if the container is undamaged".
| Device | CELLUGEL OPHTHALMIC VISCOSURGICAL |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | ALCON LABORATORIES |
| Date Received | 2003-10-24 |
| Decision Date | 2003-11-14 |
| PMA | P990023 |
| Supplement | S002 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALCON LABORATORIES 6201 South Freeway fort Worth, TX 76134 |
Supplemental Filings
| 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 |
NIH GUDID Devices