BAUSCH & LOMB SOFLENS 66 & SOFLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES

FDA Premarket Approval P960022 S008

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

Change with the supplier of the raw material processing for the soflens66 and soflens toric (alphafilcon a) soft contact lenses.

DeviceBAUSCH & LOMB SOFLENS 66 & SOFLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES
Generic NameLenses, Soft Contact, Extended Wear
ApplicantBausch & Lomb, Inc.
Date Received2011-03-03
Decision Date2011-03-28
PMAP960022
SupplementS008
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
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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