Approval for the staarvisc(tm) sodium hyaluronate viscoelastic. This device is indicated for use as a surgical aid in ophthalmic anterior and posterior segment surgery including: 1) cataract extraction with or without implantation of an intraocular lens; 2) corneal transplant surgery; 3) glaucoma filtering surgery; and secondary lens implantation. Staarvisc(tm) aids in maintaining a deep anterior chamber during surgery, protecting corneal endothelial and surrounding tissues from touch by instruments or intraocular lenses, inflating the capsular bag after cataract extraction and lubricating surgical instruments.
| Device | STAARVISC TM SODIUM HYALURONATE |
| Applicant | STAAR SUGICAL |
| Date Received | 1996-09-23 |
| Decision Date | 1999-07-02 |
| PMA | P960033 |
| Supplement | S |
| Docket Number | 99M-4693 |
| Advisory Committee | Neurology |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | STAAR SUGICAL 1911 Walker Ave. monrovia, CA 91016 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960033 | Original Filing |