Approval for an alternate packaging configuration (syringe, rubber tip cap, pouch), change in the release specification for ph, and change in the release and stability specification for osmolality.
| Device | CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (OVD) |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | ALCON LABORATORIES |
| Date Received | 2015-04-23 |
| Decision Date | 2016-02-18 |
| PMA | P990023 |
| Supplement | S013 |
| 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 | 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