CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS (IOL)

FDA Premarket Approval P030002 S019

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 modify the physician¿s labeling to include the addition of 0. 25 diopter increments for the crystalens model hd500 and hd520 as follows: the addition of 0. 25 diopter increments for model hd500 lenses in the +18 to +22 dioptric power range and for model hd520 lenses in the +16. 25 to +16. 75 dioptric power range.

DeviceCRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS (IOL)
Generic NameLens, Intraocular, Accommodative
ApplicantBausch & Lomb, Inc.
Date Received2009-05-01
Decision Date2009-06-30
PMAP030002
SupplementS019
Product CodeNAA 
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Bausch & Lomb, Inc. 50 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P030002Original Filing
S040 2021-12-22 30-day Notice
S039
S038 2016-02-01 Normal 180 Day Track
S037 2015-12-18 Normal 180 Day Track No User Fee
S036 2015-12-15 Real-time Process
S035 2015-07-02 Normal 180 Day Track No User Fee
S034 2015-04-01 Normal 180 Day Track No User Fee
S033 2015-01-26 Real-time Process
S032 2014-11-13 30-day Notice
S031 2014-04-14 30-day Notice
S030 2014-02-24 30-day Notice
S029 2014-01-16 30-day Notice
S028 2013-06-18 Normal 180 Day Track No User Fee
S027 2012-03-27 Panel Track
S026
S025 2011-08-18 30-day Notice
S024 2011-07-14 Real-time Process
S023 2011-02-24 30-day Notice
S022 2010-03-08 Real-time Process
S021 2009-08-26 Real-time Process
S020 2009-06-02 Normal 180 Day Track
S019 2009-05-01 Real-time Process
S018 2009-01-27 30-day Notice
S017 2008-08-07 30-day Notice
S016 2008-06-17 30-day Notice
S015 2008-05-15 Normal 180 Day Track No User Fee
S014 2007-12-17 Normal 180 Day Track
S013 2007-11-05 Real-time Process
S012 2007-08-28 30-day Notice
S011 2007-04-25 30-day Notice
S010 2007-04-06 Real-time Process
S009 2007-03-05 Real-time Process
S008 2006-07-24 Normal 180 Day Track No User Fee
S007
S006 2005-10-20 Normal 180 Day Track No User Fee
S005 2005-08-23 Special (immediate Track)
S004 2005-07-05 Real-time Process
S003 2005-05-04 Normal 180 Day Track No User Fee
S002 2004-08-30 Special (immediate Track)
S001 2004-06-28 Real-time Process

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