ANIKA VISC

Aid, Surgical, Viscoelastic

FDA Premarket Approval P000046 S019

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a new trade name. The device, as modified, will be marketed under the trade name anikavisc and is indicated for use during surgery in the anterior and posterior segments of the human eye.

• Device: ANIKA VISC
• Classification Name: Aid, Surgical, Viscoelastic
• Generic Name: Aid, Surgical, Viscoelastic
• Applicant: Anika Therapeutics, Inc.
• Date Received: 2010-11-01
• Decision Date: 2011-01-24
• PMA: P000046
• Supplement: S019
• Product Code: LZP
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Other Report
• 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

Device ID	PMA	Supp
00817337000012	P000046	000
00866142000021	P000046	000
00866142000038	P000046	016
00866142000045	P000046	019
30886158020067	P000046	023
00866142000052	P000046	030
00817337000128	P000046	030