MODEL UPB240 POSTERIOR CHAMBER INTRAOCULAR LENSES

Intraocular Lens

FDA Premarket Approval P860059 S064

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

DeviceMODEL UPB240 POSTERIOR CHAMBER INTRAOCULAR LENSES
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1991-04-11
Decision Date1991-10-30
PMAP860059
SupplementS064
Product CodeHQL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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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