PureVision (balafilcon A) Contact Lens

FDA Premarket Approval P980006 S032

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 to remove the sagittal depth measurement acceptance criteria from the finished product specifications for purevision (balafilcon a) contact lens.

DevicePureVision (balafilcon A) Contact Lens
Generic NameLenses, Soft Contact, Extended Wear
ApplicantBausch & Lomb, Inc.
Date Received2021-06-03
Decision Date2021-08-27
PMAP980006
SupplementS032
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
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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