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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Anika Therapeutics, Inc.
32 wiggins avenue
bedford, MA 01730
PMA NumberP000046
Date Received11/06/2000
Decision Date04/18/2001
Product Code
LZP[ Registered Establishments with LZP ]
Docket Number 01M-0227
Notice Date 05/14/2001
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for reference rights to p810025, and for staar surgical company to distribute the sodium hyaluronate under the tradename staarvisc(tm) ii. The device is indicated for use during surgery in the anterior and posterior segments of the human eye. Procedures include: cataract extraction, intraocular lens (iol) implantation, corneal transplantation surgery, glaucoma filtering surgery and surgical procedures to reattach the retina. Staarvisc9tm) ii is designed to create and maintain anterior chamber depth and visibility, protect corneal endothelial cells and other intraocular tissues, minimize interation between tissues during surgical manipulation, and act as a vitreous substitute during retinal reattachment surgery. Staarvisc(tm) ii also preserves tissue integrity and good visibility when used to fill the anterior and posterior segments of the eye following open sky procedures.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025