PMA P960033
- Device
- STAARVISC TM SODIUM HYALURONATE
- Applicant
- Staar Sugical
- PMA number
- P960033
- Decision date
- 1999-07-02
- Approval order 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 instruments or intraocular lenses, inflating the capsular bag after cataract extraction and lubricating surgical instruments.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P960033B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- STAARVISC TM SODIUM HYALURONATE
- Applicant
- Staar Sugical
- PMA number
- P960033
- Decision date
- 1999-07-02
- Decision code
- APWD
- Date received
- 1996-09-23
- Approval order 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 instruments or intraocular lenses, inflating the capsular bag after cataract extraction and lubricating surgical instruments.