Amvisc and Amvisc Plus Ophthalmic Viscosurgical (OVD)

FDA Premarket Approval P810025 S040

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 an in-process raw material quality control test affecting the sodium hyaluronate (nahy) raw material for the amvisc and amvisc plus ophthalmic viscosurgicaldevices (ovds) and change the release specification criteria for amvisc and amvisc plus ovds.

DeviceAmvisc and Amvisc Plus Ophthalmic Viscosurgical (OVD)
Generic NameAid, Surgical, Viscoelastic
ApplicantBausch & Lomb, Inc.
Date Received2020-09-02
Decision Date2020-10-01
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
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

© 2020
This site is not affiliated with or endorsed by the FDA.