MODELS 019B, 019C, 019E, 019F, 019J, & 019K

FDA Premarket Approval P810055 S037

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 019B, 019C, 019E, 019F, 019J, & 019K
Generic NameIntraocular Lens
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1989-08-22
Decision Date1990-03-19
PMAP810055
SupplementS037
Product CodeHQL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation 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
P810055Original Filing
S072 2008-05-29 30-day Notice
S071 2005-01-03 Real-time Process
S070 1998-06-23 Real-time Process
S069 1998-03-27 Normal 180 Day Track
S068 1997-05-14 Normal 180 Day Track
S067 1997-03-06 Normal 180 Day Track
S066 1996-05-23 Normal 180 Day Track
S065
S064
S063 1993-01-11 Normal 180 Day Track
S062
S061 1992-09-14 Normal 180 Day Track
S060
S059 1992-08-10 Normal 180 Day Track
S058 1992-08-10 Normal 180 Day Track
S057 1992-08-04 Normal 180 Day Track
S056 1992-07-17 Normal 180 Day Track
S055 1992-05-26 Normal 180 Day Track
S054 1992-04-15 Normal 180 Day Track
S053 1992-04-09 Normal 180 Day Track
S052 1991-08-09 Normal 180 Day Track
S051 1991-04-15 Normal 180 Day Track
S050 1991-01-08 Normal 180 Day Track
S049
S048
S047 1990-06-29 Normal 180 Day Track
S046
S045
S044 1990-03-26 Normal 180 Day Track
S043 1990-03-12 Normal 180 Day Track
S042 1990-02-01 Normal 180 Day Track
S041 1989-12-15 Normal 180 Day Track
S040 1989-11-30 Normal 180 Day Track
S039 1989-11-30 Normal 180 Day Track
S038 1989-10-25 Normal 180 Day Track
S037 1989-08-22 Normal 180 Day Track
S036
S035
S034 1989-01-31 Normal 180 Day Track
S033 1988-12-19 Normal 180 Day Track
S032 1988-10-27 30-Day Supplement
S031 1988-08-29 Normal 180 Day Track
S030 1988-05-23 Normal 180 Day Track
S029 1988-03-09 Normal 180 Day Track
S028 1988-01-11 Normal 180 Day Track
S027 1987-12-15 Normal 180 Day Track
S026 1987-11-19 Normal 180 Day Track
S025 1987-11-02 Normal 180 Day Track
S024 1987-10-13 Normal 180 Day Track
S023 1987-10-19 Normal 180 Day Track
S022 1987-08-17 Normal 180 Day Track
S021 1987-07-20 Normal 180 Day Track
S020 1987-06-23 Normal 180 Day Track
S019 1987-04-30 Normal 180 Day Track
S018 1986-11-19 Normal 180 Day Track
S017 1986-03-28 Panel Track
S016 1985-05-02
S015 1985-05-02
S014 1985-04-22
S013 1985-04-11
S012 1984-10-01
S011
S010 1984-05-31
S009
S008 1983-12-02
S007
S006 1983-09-02
S005 1983-08-08
S004 1983-06-09
S003 1983-05-31
S002 1983-04-08
S001

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