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.
| Device | STAARVISC II |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Anika Therapeutics, Inc. |
| Date Received | 2000-11-06 |
| Decision Date | 2001-04-18 |
| Notice Date | 2001-05-14 |
| PMA | P000046 |
| Supplement | S |
| Product Code | LZP |
| Docket Number | 01M-0227 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000046 | | Original Filing |
| S030 |
2021-11-23 |
Normal 180 Day Track No User Fee |
| S029 |
2021-07-29 |
Normal 180 Day Track No User Fee |
| S028 |
2021-05-04 |
30-day Notice |
| S027 |
2019-05-24 |
Real-time Process |
| S026 |
2017-02-14 |
Normal 180 Day Track No User Fee |
| S025 |
2014-06-10 |
30-day Notice |
| S024 |
2014-06-02 |
30-day Notice |
| S023 |
2014-01-15 |
Normal 180 Day Track No User Fee |
| S022 |
2013-12-27 |
30-day Notice |
| S021 |
2013-12-26 |
30-day Notice |
| S020 |
2011-11-04 |
30-day Notice |
| S019 |
2010-11-01 |
Normal 180 Day Track No User Fee |
| S018 |
2010-11-03 |
30-day Notice |
| S017 |
2010-09-30 |
Normal 180 Day Track No User Fee |
| S016 |
2009-10-02 |
Normal 180 Day Track No User Fee |
| S015 |
2009-05-27 |
Normal 180 Day Track |
| S014 |
2006-07-24 |
30-day Notice |
| S013 |
2006-01-03 |
30-day Notice |
| S012 |
2005-09-07 |
Special (immediate Track) |
| S011 |
2005-07-07 |
Special (immediate Track) |
| S010 |
2004-06-17 |
30-day Notice |
| S009 |
2004-05-07 |
30-day Notice |
| S008 |
2003-04-25 |
30-day Notice |
| S007 |
2002-11-27 |
Normal 180 Day Track |
| S006 |
2002-10-15 |
Normal 180 Day Track |
| S005 | | |
| S004 |
2002-05-21 |
Normal 180 Day Track |
| S003 |
2002-04-17 |
Real-time Process |
| S002 |
2002-03-18 |
Normal 180 Day Track |
| S001 |
2001-05-10 |
Real-time Process |
NIH GUDID Devices