HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML

FDA Premarket Approval P860047

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

DeviceHYDROXYPROPYLMETHYLCELLULOSE 20MG/ML
Generic NameAid, Surgical, Viscoelastic
ApplicantBausch & Lomb, Inc.
Date Received1986-10-06
Decision Date1988-07-12
Notice Date1988-08-18
PMAP860047
SupplementS
Product CodeLZP 
Docket Number88M-0271
Advisory CommitteeOphthalmic
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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