BAUSCH & LOMB PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P980006 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

Approval for a multifocal design of the bausch & lomb purevision visibility tinted contact lenses and is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2. 00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for frequent/planned replacement wear or disposable wear in spherical powers ranging from +6. 00d to -18. 00d when prescribed for up to 30 days of extended wear and from +20. 00 to -20. 00 for daily wear or extended wear up to 7 days with add powers ranging from +0. 75 to +5. 00d.

DeviceBAUSCH & LOMB PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantBausch & Lomb, Inc.
Date Received2005-04-25
Decision Date2005-05-27
PMAP980006
SupplementS008
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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
S035 2022-08-12 30-day Notice
S034 2022-02-22 30-day Notice
S033 2021-12-15 30-day Notice
S032 2021-06-03 Real-time Process
S031
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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