MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Premarket Approval P810055 S068

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 extend the dioptric power range of model 812b to -10d to +40d. The device is indicated for use in the visual correction of aphakia in patients 60 years of age and older, who are undergoing a primary lens implantation, in either the ciliary sulcus or capsular bag following an extracapsular cataract extraction.

DeviceMODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1997-05-14
Decision Date1997-10-22
PMAP810055
SupplementS068
Product CodeHQL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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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