PMMA Anterior Chamber Intraocular Lenses

Intraocular Lens

FDA Premarket Approval P880090 S030

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

Ethylene oxide and ethylene chlorohydrin residual testing for the silicone and pmma intraocular lenses be transferred to a new testing laboratory.

DevicePMMA Anterior Chamber Intraocular Lenses
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantBausch & Lomb, Inc.
Date Received2019-01-04
Decision Date2019-02-28
PMAP880090
SupplementS030
Product CodeHQL
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Bausch & Lomb, Inc. 50 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P880090Original Filing
S030 2019-01-04 30-day Notice
S029 2016-05-17 30-day Notice
S028
S027 2009-11-02 30-day Notice
S026 2009-06-19 30-day Notice
S025 2008-06-19 30-day Notice
S024 2008-04-04 Real-time Process
S023 2008-04-03 30-day Notice
S022
S021 2004-03-29 Normal 180 Day Track No User Fee
S020 2004-03-18 Real-time Process
S019 2003-06-23 30-day Notice
S018 2003-06-11 Real-time Process
S017 1995-12-19 Normal 180 Day Track
S016 1994-11-21 Normal 180 Day Track
S015 1994-06-02 Normal 180 Day Track
S014 1993-12-16 Normal 180 Day Track
S013 1993-02-16 Normal 180 Day Track
S012 1992-12-29 Normal 180 Day Track
S011 1992-09-14 Normal 180 Day Track
S010 1992-08-17 Normal 180 Day Track
S009 1992-01-10 Normal 180 Day Track
S008 1991-10-15 Normal 180 Day Track
S007 1991-10-08 Normal 180 Day Track
S006 1990-09-26 Normal 180 Day Track
S005 1990-09-10 Special (immediate Track)
S004 1990-06-06 Normal 180 Day Track
S003 1990-02-02 Normal 180 Day Track
S002 1988-12-22 Normal 180 Day Track
S001 1988-12-19 Normal 180 Day Track

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