Approval for the silikon 1000. This device is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (pvr), proliferative diabetic retinopathy (pdr), cytomegalovirus (cmv) retinitis, giant tears, and following perofrating injuries. Silikon 1000 is also indicated for primary use in detachments due to aids) related cmv retinitis and other viral infections affecting the retina.
| Device | SILIKON 1000 |
| Classification Name | Fluid, Intraocular |
| Generic Name | Fluid, Intraocular |
| Applicant | ALCON |
| Date Received | 1995-02-22 |
| Decision Date | 1997-09-25 |
| Notice Date | 1997-09-30 |
| PMA | P950008 |
| Supplement | S |
| Product Code | LWL |
| Docket Number | 97M-0521 |
| Advisory Committee | Ophthalmic |
| Expedited Review | Yes |
| 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