OcuCoat OVD

FDA Premarket Approval P860047 S034

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 to utilize a new facility to perform analytical quality control testing of the amvisc/amvisc plus and ocucoat fill/finish products

DeviceOcuCoat OVD
Generic NameAid, Surgical, Viscoelastic
ApplicantBausch & Lomb, Inc.
Date Received2020-06-15
Decision Date2021-01-13
PMAP860047
SupplementS034
Product CodeLZP 
Advisory CommitteeOphthalmic
Supplement Type135 Review Track For 30-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
P860047Original Filing
S034 2020-06-15 135 Review Track For 30-day Notice
S033 2016-11-23 Normal 180 Day Track
S032 2016-08-23 Normal 180 Day Track No User Fee
S031 2015-07-01 Normal 180 Day Track
S030
S029 2014-12-24 Real-time Process
S028 2014-03-07 30-day Notice
S027 2012-12-31 30-day Notice
S026 2012-07-02 30-day Notice
S025 2010-11-18 Normal 180 Day Track
S024 2010-07-21 Normal 180 Day Track No User Fee
S023 2009-11-02 30-day Notice
S022 2008-06-19 30-day Notice
S021 2008-06-12 Real-time Process
S020 2007-10-04 Normal 180 Day Track
S019 2006-01-24 Normal 180 Day Track No User Fee
S018 2004-03-29 Normal 180 Day Track No User Fee
S017
S016 2004-03-18 Real-time Process
S015 2003-05-08 135 Review Track For 30-day Notice
S014 2003-05-08 30-day Notice
S013 2003-04-10 30-day Notice
S012 2003-03-20 30-day Notice
S011 1996-05-13 Normal 180 Day Track
S010 1995-05-31 Normal 180 Day Track
S009 1995-04-24 Normal 180 Day Track
S008 1994-06-03 Normal 180 Day Track
S007 1993-03-08 Normal 180 Day Track
S006
S005 1992-02-28 Normal 180 Day Track
S004 1992-02-25 Normal 180 Day Track
S003 1992-02-25 Normal 180 Day Track
S002 1990-06-07 Normal 180 Day Track
S001 1989-11-09 Normal 180 Day Track

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