Bausch + Lomb PureVision (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses

FDA Premarket Approval P980006 S030

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

Qualification of an additional manufacturer of a raw material for bausch + lomb ultra (samfilcon a) visibility tinted soft (hydrophilic) contact lenses and bausch + lomb purevision (balafilcon a) visibility tinted soft (hydrophilic) contact lenses.

DeviceBausch + Lomb PureVision (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses
Generic NameLenses, Soft Contact, Extended Wear
ApplicantBausch & Lomb, Inc.
Date Received2020-09-02
Decision Date2020-09-28
PMAP980006
SupplementS030
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Bausch & Lomb, Inc. 1400 North Goodman St. rochester, NY 14609-3547

Supplemental Filings

Supplement NumberDateSupplement Type
P980006Original Filing
S030 2020-09-02 30-day Notice
S029 2019-07-15 Real-time Process
S028
S027 2018-03-12 30-day Notice
S026 2017-12-26 30-day Notice
S025 2015-11-20 30-day Notice
S024 2015-02-20 30-day Notice
S023 2014-09-15 30-day Notice
S022 2014-04-14 Normal 180 Day Track No User Fee
S021 2013-06-24 30-day Notice
S020 2011-06-08 30-day Notice
S019 2011-05-19 30-day Notice
S018 2010-12-03 Normal 180 Day Track No User Fee
S017 2010-12-01 30-day Notice
S016 2010-12-01 30-day Notice
S015 2010-07-22 Normal 180 Day Track
S014 2008-11-12 Real-time Process
S013 2008-09-24 Real-time Process
S012 2008-04-02 Real-time Process
S011 2007-08-20 30-day Notice
S010 2006-08-24 30-day Notice
S009
S008 2005-04-25 Real-time Process
S007 2005-03-03 Normal 180 Day Track
S006 2005-02-03 Real-time Process
S005 2004-01-06 Normal 180 Day Track No User Fee
S004 2001-05-30 Panel Track
S003 2001-01-09 Normal 180 Day Track
S002 1999-09-01 Normal 180 Day Track
S001 1999-06-29 Normal 180 Day Track

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