BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES

FDA Premarket Approval P960022 S007

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 for a name change to the currently marketed bausch & lomb soflens 66 toric (alphafilcon a) visibility tinted contact lenses. The proposed name for the device is bausch & lomb soflens toric (alphafilcon a) visibility tinted contact lenses.

DeviceBAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES
Generic NameLenses, Soft Contact, Extended Wear
ApplicantBausch & Lomb, Inc.
Date Received2010-11-15
Decision Date2011-02-18
PMAP960022
SupplementS007
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Bausch & Lomb, Inc. 1400 North Goodman St. rochester, NY 14609-3547

Supplemental Filings

Supplement NumberDateSupplement Type
P960022Original Filing
S012 2020-03-20 30-day Notice
S011 2015-09-29 30-day Notice
S010 2013-10-17 30-day Notice
S009 2011-10-19 135 Review Track For 30-day Notice
S008 2011-03-03 30-day Notice
S007 2010-11-15 Normal 180 Day Track No User Fee
S006 2010-05-17 30-day Notice
S005 2008-09-24 Real-time Process
S004 2004-02-06 30-day Notice
S003 2003-03-03 Real-time Process
S002 2001-01-09 Normal 180 Day Track
S001 1997-08-07 Normal 180 Day Track

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