PMMA SINGLE-PIECE ANTERIOR CHAMBER IOLS

FDA Premarket Approval P880087 S018

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

Change in the packaging system.

DevicePMMA SINGLE-PIECE ANTERIOR CHAMBER IOLS
Generic NameIntraocular Lens
ApplicantALCON LABORATORIES
Date Received2010-08-25
Decision Date2010-09-22
PMAP880087
SupplementS018
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ALCON LABORATORIES 6201 S Freeway ft Worth, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P880087Original Filing
S031 2021-06-21 Normal 180 Day Track No User Fee
S030 2020-11-25 30-day Notice
S029 2019-07-05 30-day Notice
S028 2019-03-25 30-day Notice
S027 2019-03-25 30-day Notice
S026 2016-11-30 30-day Notice
S025 2016-08-03 30-day Notice
S024
S023 2015-12-09 30-day Notice
S022 2013-04-22 30-day Notice
S021 2012-12-26 Normal 180 Day Track No User Fee
S020 2012-10-01 30-day Notice
S019 2011-06-24 30-day Notice
S018 2010-08-25 30-day Notice
S017 2010-08-10 30-day Notice
S016 2010-05-03 30-day Notice
S015 2010-05-03 30-day Notice
S014 2009-12-24 30-day Notice
S013 2009-06-30 30-day Notice
S012 2006-07-24 30-day Notice
S011 2004-10-18 135 Review Track For 30-day Notice
S010 2004-04-16 Real-time Process
S009 1996-10-24 Normal 180 Day Track
S008
S007 1996-08-08 Normal 180 Day Track
S006 1995-08-09 Normal 180 Day Track
S005 1995-01-31 Normal 180 Day Track
S004 1991-08-21 Normal 180 Day Track
S003
S002 1990-03-26 Normal 180 Day Track
S001

NIH GUDID Devices

Device IDPMASupp
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