AMVISC(R)

FDA Premarket Approval P810025

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceAMVISC(R)
Generic NameAid, Surgical, Viscoelastic
ApplicantBausch & Lomb, Inc.
Date Received1981-05-28
Decision Date1983-10-18
Notice Date1983-11-28
PMAP810025
SupplementS
Product CodeLZP 
Docket Number83M-0374
Advisory CommitteeOphthalmic
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
S039
S038 2016-11-23 Normal 180 Day Track
S037 2016-08-23 Normal 180 Day Track No User Fee
S036
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
S019
S018
S017
S016
S015 1994-07-26 Normal 180 Day Track
S014
S013 1988-12-23 Normal 180 Day Track
S012
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.