Ophthalmic

FDA Premarket Approval P000046 S028

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

The use of an alternate stopper from the current supplier for the syringe that holds your approved ophthalmic viscosurgical device

DeviceOphthalmic
Generic NameAid, Surgical, Viscoelastic
ApplicantAnika Therapeutics, Inc.
Date Received2021-05-04
Decision Date2021-06-02
PMAP000046
SupplementS028
Product CodeLZP 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730

Supplemental Filings

Supplement NumberDateSupplement Type
P000046Original Filing
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

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