MODELS B-13F (P-10) & B-1H (P-11)

Intraocular Lens

FDA Premarket Approval P810032 S003

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

DeviceMODELS B-13F (P-10) & B-1H (P-11)
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantALCON LABORATORIES
Date Received1983-06-17
Decision Date1983-07-27
PMAP810032
SupplementS003
Product CodeHQL
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address ALCON LABORATORIES 6201 S Freeway ft Worth, TX 76134

Supplemental Filings

Supplement NumberDateSupplement Type
P810032Original Filing
S070 2019-07-05 30-day Notice
S069 2019-03-25 30-day Notice
S068 2019-03-25 30-day Notice
S067 2016-11-30 30-day Notice
S066 2016-08-03 30-day Notice
S065 2016-07-29 135 Review Track For 30-day Notice
S064 2015-12-09 30-day Notice
S063 2012-12-26 Normal 180 Day Track No User Fee
S062 2012-10-01 30-day Notice
S061 2012-05-29 30-day Notice
S060 2011-06-24 30-day Notice
S059 2010-08-25 30-day Notice
S058 2010-08-10 30-day Notice
S057 2010-05-03 30-day Notice
S056 2010-05-03 30-day Notice
S055 2009-12-24 30-day Notice
S054 2009-06-30 30-day Notice
S053 2007-01-16 30-day Notice
S052 2006-07-24 30-day Notice
S051 2004-10-18 135 Review Track For 30-day Notice
S050 2004-04-16 Real-time Process
S049 1996-08-08 Normal 180 Day Track
S048 1995-08-09 Normal 180 Day Track
S047 1995-01-31
S046
S045 1993-02-17 Normal 180 Day Track
S044 1992-04-16 Normal 180 Day Track
S043 1991-08-21 Normal 180 Day Track
S042 1991-07-10 Normal 180 Day Track
S041 1991-06-25 Normal 180 Day Track
S040
S039
S038
S037
S036
S035
S034
S033
S032
S031
S030 1988-12-29 Normal 180 Day Track
S029
S028 1988-12-22 Normal 180 Day Track
S027 1988-11-23 Normal 180 Day Track
S026 1988-11-14 Normal 180 Day Track
S025 1988-11-08 Normal 180 Day Track
S024 1988-08-30 Normal 180 Day Track
S023
S022
S021 1988-06-28 Normal 180 Day Track
S020 1988-05-31 Normal 180 Day Track
S019
S018
S017 1988-05-09 Normal 180 Day Track
S016 1987-12-24 Normal 180 Day Track
S015 1987-12-14 Normal 180 Day Track
S014 1987-12-14 Normal 180 Day Track
S013 1987-05-18 Normal 180 Day Track
S012 1987-04-15 Normal 180 Day Track
S011 1986-12-22 Normal 180 Day Track
S010 1986-08-14 Normal 180 Day Track
S009
S008 1986-01-23
S007 1985-12-24
S006 1985-08-09
S005 1984-01-26
S004 1983-07-21
S003 1983-06-17
S002
S001 1982-12-28

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