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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1911 walker ave.
monrovia, CA 91016
PMA NumberP960033
Date Received09/23/1996
Decision Date07/02/1999
Withdrawal Date 10/15/2007
Docket Number 99M-4693
Advisory Committee Neurology
Expedited Review Granted? No
Combination Product Yes
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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling