Amvisc Ophthalmic Viscosurgical , Amvisc Plus Ophthalmic Viscosurgical (OVD)

FDA Premarket Approval P810025 S043

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

Changes of the sodium hyaluronate release specifications to align with the european pharmacopoeia

DeviceAmvisc Ophthalmic Viscosurgical , Amvisc Plus Ophthalmic Viscosurgical (OVD)
Generic NameAid, Surgical, Viscoelastic
ApplicantBausch & Lomb, Inc.
Date Received2021-08-03
Decision Date2021-08-27
Product CodeLZP 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Bausch & Lomb, Inc. 50 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P810025Original Filing
S043 2021-08-03 30-day Notice
S042 2021-06-09 30-day Notice
S041 2021-03-16 30-day Notice
S040 2020-09-02 30-day Notice
S038 2016-11-23 Normal 180 Day Track
S037 2016-08-23 Normal 180 Day Track No User Fee
S035 2014-08-01 30-day Notice
S034 2013-07-15 30-day Notice
S033 2013-03-21 30-day Notice
S032 2012-06-28 30-day Notice
S031 2012-06-27 Special (immediate Track)
S030 2010-11-03 30-day Notice
S029 2010-09-30 Normal 180 Day Track No User Fee
S028 2010-06-21 Normal 180 Day Track
S027 2009-05-27 Normal 180 Day Track
S026 2006-07-27 30-day Notice
S025 2006-02-17 30-day Notice
S024 2004-06-24 30-day Notice
S023 2004-05-12 30-day Notice
S022 2003-04-29 135 Review Track For 30-day Notice
S021 2002-05-10 Normal 180 Day Track
S020 2002-03-22 Normal 180 Day Track
S015 1994-07-26 Normal 180 Day Track
S013 1988-12-23 Normal 180 Day Track
S011 1988-07-01 Normal 180 Day Track
S010 1988-05-03 Normal 180 Day Track
S009 1988-01-25 Normal 180 Day Track
S008 1988-01-05 Normal 180 Day Track
S007 1987-11-03 Special (immediate Track)
S006 1987-08-10 Normal 180 Day Track
S005 1985-11-13
S004 1985-03-18
S003 1984-12-17
S002 1984-02-10
S001 1984-02-10

© 2021
This site is not affiliated with or endorsed by the FDA.