Ophthalmic Viscoelastic

Aid, Surgical, Viscoelastic

FDA Premarket Approval P000046 S027

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 an extension of the shelf-life of ophthalmic viscoelastic® from 24 months to 36 months

DeviceOphthalmic Viscoelastic
Classification NameAid, Surgical, Viscoelastic
Generic NameAid, Surgical, Viscoelastic
ApplicantAnika Therapeutics, Inc.
Date Received2019-05-24
Decision Date2019-08-28
PMAP000046
SupplementS027
Product CodeLZP
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730

Supplemental Filings

Supplement NumberDateSupplement Type
P000046Original 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 IDPMASupp
00817337000012 P000046 000
00866142000021 P000046 000
00866142000038 P000046 016
00866142000045 P000046 019
30886158020067 P000046 023
00866142000052 P000046 030
00817337000128 P000046 030
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