STAARVISC TM SODIUM HYALURONATE
FDA premarket approval P960033 · decided 1999-07-02
Approval details
- PMA number
- P960033
- Trade name
- STAARVISC TM SODIUM HYALURONATE
- Applicant
- Staar Sugical
- Date received
- 1996-09-23
- Decision date
- 1999-07-02
- Days to decision
- 1012 days
- Decision code
- APWD
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- 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 instrum
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE MICROSTAAR INJECTOR (K940593) | Staar Sugical | 1994-09-19 |