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

FDA Premarket Approval P170035 S009

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

Supplemental Filings

Supplement NumberDateSupplement Type
P170035Original Filing
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
S004 2019-06-14 30-day Notice
S003 2019-02-04 Normal 180 Day Track

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