MODELS PC10 & PC21

Intraocular Lens

FDA Premarket Approval P820049 S008

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 PC10 & PC21
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1986-03-28
Decision Date1986-09-24
PMAP820049
SupplementS008
Product CodeHQL
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 1700 East St. Andrew Pl. santa Ana, CA 92705

Supplemental Filings

Supplement NumberDateSupplement Type
P820049Original Filing
S064 1997-06-30 Real-time Process
S063 1995-11-13 Normal 180 Day Track
S062 1995-11-03 Normal 180 Day Track
S061 1995-04-04 Normal 180 Day Track
S060 1994-12-30 Normal 180 Day Track
S059 1993-12-16 Normal 180 Day Track
S058 1993-06-16 Normal 180 Day Track
S057 1993-05-10 Normal 180 Day Track
S056 1993-01-21 Normal 180 Day Track
S055 1992-07-21 Normal 180 Day Track
S054 1992-06-30 Normal 180 Day Track
S053 1991-03-12 Normal 180 Day Track
S052 1991-01-25 Normal 180 Day Track
S051 1990-12-19 Normal 180 Day Track
S050 1990-09-06 Normal 180 Day Track
S049 1990-02-28 Normal 180 Day Track
S048 1989-12-26 Normal 180 Day Track
S047 1989-03-17 Normal 180 Day Track
S046 1989-03-17 Normal 180 Day Track
S045 1989-03-17 Normal 180 Day Track
S044 1988-12-21 Normal 180 Day Track
S043 1988-12-05 Normal 180 Day Track
S042 1988-12-02 Normal 180 Day Track
S041
S040
S039 1988-08-10 Normal 180 Day Track
S038 1988-08-01 Normal 180 Day Track
S037 1988-07-19 Normal 180 Day Track
S036 1988-05-03 Normal 180 Day Track
S035 1988-02-29 Normal 180 Day Track
S034 1988-02-29 Normal 180 Day Track
S033 1987-12-31 Normal 180 Day Track
S032 1987-10-13 Normal 180 Day Track
S031 1987-10-26 Normal 180 Day Track
S030
S029 1987-08-28 Normal 180 Day Track
S028 1987-08-31 Normal 180 Day Track
S027 1987-08-19 Normal 180 Day Track
S026 1987-08-07 Normal 180 Day Track
S025 1987-07-09 Normal 180 Day Track
S024 1987-06-24 Normal 180 Day Track
S023 1987-06-08 Normal 180 Day Track
S022 1987-05-28 Normal 180 Day Track
S021 1987-05-01 Normal 180 Day Track
S020 1987-04-28 Normal 180 Day Track
S019 1987-03-25 Normal 180 Day Track
S018 1986-12-29 Normal 180 Day Track
S017 1986-12-02 Normal 180 Day Track
S016 1986-11-25 Normal 180 Day Track
S015 1986-11-24 Normal 180 Day Track
S014 1986-11-21 Normal 180 Day Track
S013 1986-11-06 Normal 180 Day Track
S012 1986-10-27 Normal 180 Day Track
S011 1986-10-02 Normal 180 Day Track
S010 1986-09-23 Normal 180 Day Track
S009 1986-04-24
S008 1986-03-28
S007 1986-02-28
S006 1985-12-23
S005 1985-11-25
S004 1985-11-18
S003 1985-07-15
S002 1984-06-21
S001 1984-03-05

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