Approval for a new trade name. The device, as modified, will be marketed under the trade name nuvisctm and 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.
| Device | NUVISC |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Anika Therapeutics, Inc. |
| Date Received | 2014-01-15 |
| Decision Date | 2014-04-10 |
| PMA | P000046 |
| Supplement | S023 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730 |
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