Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lens

FDA Premarket Approval P170035 S017

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

DeviceBausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lens
Generic NameLenses, Soft Contact, Extended Wear
ApplicantBausch And Lomb, Inc.1400 North Goodman Streetrochester, NY 14609 PMA NumberP170035 Supplement NumberS017 Date Received05/04/2022 Decision Date06/01/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-04
Decision Date2022-06-01
PMAP170035
SupplementS017
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressBausch And Lomb, Inc.
1400 North Goodman Street
rochester, NY 14609 PMA NumberP170035 Supplement NumberS017 Date Received05/04/2022 Decision Date06/01/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
implementation Of A New Power Measurement Method On The Spin-Blot System For Bausch + Lomb Ultra® (samfilcon A)Visibility Tinted Soft (hydrophilic) Contact Lenses For Presbyopia Vision Correction

Supplemental Filings

Supplement NumberDateSupplement Type
P170035Original Filing
S017 2022-05-04 30-day Notice
S016 2022-02-22 30-day Notice
S015 2021-12-15 30-day Notice
S014
S013 2021-06-03 Real-time Process
S012 2021-03-12 30-day Notice
S011 2020-10-30 30-day Notice
S010 2020-09-29 30-day Notice
S009 2020-09-02 30-day Notice
S008 2020-06-18 30-day Notice
S007 2019-11-20 30-day Notice
S006 2019-08-14 30-day Notice
S005
S004 2019-06-14 30-day Notice
S003 2019-02-04 Normal 180 Day Track
S002
S001

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