STAARVISC II, SHELLGEL AND COEASE

Aid, Surgical, Viscoelastic

FDA Premarket Approval P000046 S013

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

Removal of the chloroform treatment step from the manufacturing process.

• Device: STAARVISC II, SHELLGEL AND COEASE
• Classification Name: Aid, Surgical, Viscoelastic
• Generic Name: Aid, Surgical, Viscoelastic
• Applicant: Anika Therapeutics, Inc.
• Date Received: 2006-01-03
• Decision Date: 2006-01-24
• PMA: P000046
• Supplement: S013
• Product Code: LZP
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• 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