IOPTEX PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)

FDA Premarket Approval P860059 S077

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

Reduction of the incubation time for biological indicators used in sterility testing

DeviceIOPTEX PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
Generic NameIntraocular Lens
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1996-04-10
Decision Date1996-10-07
PMAP860059
SupplementS077
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 1700 E. St. Andrew Place p.o. Box 25162 santa Ana, CA 92705-4933

Supplemental Filings

Supplement NumberDateSupplement Type
P860059Original Filing
S077 1996-04-10 Normal 180 Day Track
S076 1996-04-05 Normal 180 Day Track
S075 1996-03-06 Normal 180 Day Track
S074 1992-09-28 Normal 180 Day Track
S073 1992-09-28 Normal 180 Day Track
S072
S071 1992-08-20 Normal 180 Day Track
S070 1992-07-28 Normal 180 Day Track
S069 1992-02-25 Normal 180 Day Track
S068 1991-11-01 Normal 180 Day Track
S067 1991-10-28 Normal 180 Day Track
S066 1991-10-07 Normal 180 Day Track
S065 1991-06-24 Normal 180 Day Track
S064 1991-04-11 Normal 180 Day Track
S063 1991-04-04 Normal 180 Day Track
S062 1991-01-16 Normal 180 Day Track
S061 1991-01-16 Normal 180 Day Track
S060
S059 1991-01-11 Normal 180 Day Track
S058 1991-01-11 Normal 180 Day Track
S057
S056 1990-11-28 Normal 180 Day Track
S055
S054 1990-11-16 Normal 180 Day Track
S053 1990-11-07 Normal 180 Day Track
S052
S051 1990-11-07 Normal 180 Day Track
S050 1990-10-03 Normal 180 Day Track
S049 1989-12-08 Normal 180 Day Track
S048 1989-11-22 Normal 180 Day Track
S047
S046 1989-09-26 Normal 180 Day Track
S045 1989-08-23 Normal 180 Day Track
S044
S043
S042
S041
S040
S039
S038
S037 1989-02-21 Normal 180 Day Track
S036 1988-12-23 Normal 180 Day Track
S035
S034
S033 1988-12-20 Normal 180 Day Track
S032
S031 1988-12-16 Normal 180 Day Track
S030
S029 1988-11-21 Normal 180 Day Track
S028
S027
S026 1988-11-16 Normal 180 Day Track
S025
S024
S023 1988-11-10 Normal 180 Day Track
S022
S021 1988-10-31 Normal 180 Day Track
S020 1988-10-27 Normal 180 Day Track
S019 1988-10-26 Normal 180 Day Track
S018
S017 1988-10-04 Normal 180 Day Track
S016 1988-09-29 Normal 180 Day Track
S015 1988-09-26 Normal 180 Day Track
S014 1988-09-15 Normal 180 Day Track
S013 1988-09-09 Normal 180 Day Track
S012
S011 1988-08-18 Normal 180 Day Track
S010 1988-08-10 Normal 180 Day Track
S009 1988-08-03 Normal 180 Day Track
S008 1988-05-19 Normal 180 Day Track
S007 1988-04-07 Normal 180 Day Track
S006 1988-04-07 Normal 180 Day Track
S005 1988-03-15 Normal 180 Day Track
S004 1988-03-10 Normal 180 Day Track
S003 1988-01-05 Panel Track
S002 1987-12-24 Normal 180 Day Track
S001 1987-11-03 Normal 180 Day Track

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