MODELS PC10 & PC21

Intraocular Lens

FDA Premarket Approval P820049 S022

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 Received1987-05-28
Decision Date1987-11-24
PMAP820049
SupplementS022
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 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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