Approval for modifications of specification ranges for viscosity and molecular weight. The current specifications for viscosity and molecular weight are 900 ¿ 1,250 cs and 32,850 ¿ 47,000 daltons, respectively. The proposed regulatory acceptance specifications for viscosity and molecular weight are 980 ¿ 1,350 cs and 31,000 ¿ 44,500 daltons, respectively.
| Device | SILIKON 1000 |
| Classification Name | Fluid, Intraocular |
| Generic Name | Fluid, Intraocular |
| Applicant | ALCON |
| Date Received | 2009-05-04 |
| Decision Date | 2009-10-30 |
| PMA | P950008 |
| Supplement | S007 |
| Product Code | LWL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALCON 6201 South Freeway mail Drop R7-14 fort Worth, TX 76134-2099 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P950008 | | Original Filing |
| S015 |
2021-01-19 |
30-day Notice |
| S014 |
2018-05-08 |
Special (immediate Track) |
| S013 |
2016-06-24 |
30-day Notice |
| S012 |
2014-07-07 |
Normal 180 Day Track No User Fee |
| S011 |
2013-10-22 |
30-day Notice |
| S010 |
2013-06-11 |
Special (immediate Track) |
| S009 |
2013-04-10 |
30-day Notice |
| S008 |
2011-02-11 |
30-day Notice |
| S007 |
2009-05-04 |
Real-time Process |
| S006 |
2003-12-15 |
Real-time Process |
| S005 | | |
| S004 |
2001-12-06 |
30-day Notice |
| S003 |
2001-10-04 |
Normal 180 Day Track |
| S002 |
2001-01-22 |
Real-time Process |
| S001 |
2000-06-19 |
Real-time Process |
NIH GUDID Devices