MENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES

Intraocular Lens

FDA Premarket Approval P830056 S079

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 for posterior chamber intraocular lens models c451f, c421f, and c455a5. These lenses are intended to be used for primary implantation for the visual correction of aphakia in patients 60 years of age or older where a cataractous lens has been removed using extracapsular extraction methods. The lenses are intended to be placed in either the ciliary sulcus or capsular bag.

DeviceMENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantCARL ZEISS MEDITEC AG
Date Received1998-11-12
Decision Date1999-05-11
PMAP830056
SupplementS079
Product CodeHQL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CARL ZEISS MEDITEC AG 5160 Hacienda Drive dublin, CA 94568

Supplemental Filings

Supplement NumberDateSupplement Type
P830056Original Filing
S079 1998-11-12 Normal 180 Day Track
S078 1996-07-23 Normal 180 Day Track
S077 1996-05-31 Normal 180 Day Track
S076
S075 1994-06-17 Normal 180 Day Track
S074 1993-02-19 Normal 180 Day Track
S073
S072 1990-09-26 Normal 180 Day Track
S071 1990-09-26 Normal 180 Day Track
S070 1990-09-19 Normal 180 Day Track
S069 1990-09-17 Normal 180 Day Track
S068
S067
S066
S065
S064
S063
S062
S061 1989-02-24 Normal 180 Day Track
S060 1989-01-10 Normal 180 Day Track
S059
S058
S057
S056
S055 1988-12-15 Normal 180 Day Track
S054
S053
S052
S051
S050 1988-11-22 Normal 180 Day Track
S049
S048
S047 1988-10-04 Normal 180 Day Track
S046 1988-09-29 Normal 180 Day Track
S045
S044 1988-09-26 Normal 180 Day Track
S043 1988-09-21 Normal 180 Day Track
S042 1988-09-13 Normal 180 Day Track
S041 1988-08-25 Normal 180 Day Track
S040 1988-07-26 Normal 180 Day Track
S039 1988-05-03 Normal 180 Day Track
S038
S037
S036 1988-03-31 Normal 180 Day Track
S035 1988-01-07 Normal 180 Day Track
S034
S033 1987-12-24 Normal 180 Day Track
S032 1987-10-26 Normal 180 Day Track
S031 1987-09-11 Normal 180 Day Track
S030 1987-08-17 Normal 180 Day Track
S029 1987-08-11 Normal 180 Day Track
S028 1987-07-21 Normal 180 Day Track
S027 1987-03-24 Normal 180 Day Track
S026 1987-03-04 Normal 180 Day Track
S025 1987-02-19 Normal 180 Day Track
S024 1987-01-16 Normal 180 Day Track
S023 1986-12-05 Normal 180 Day Track
S022 1986-10-28 Normal 180 Day Track
S021 1986-11-12 Normal 180 Day Track
S020 1986-11-12 Normal 180 Day Track
S019 1986-11-12 Normal 180 Day Track
S018 1986-11-12 Normal 180 Day Track
S017 1986-11-07 Normal 180 Day Track
S016 1986-10-31 Normal 180 Day Track
S015 1986-10-22 Normal 180 Day Track
S014 1986-08-25 Normal 180 Day Track
S013 1986-08-06 Normal 180 Day Track
S012 1986-08-06 Normal 180 Day Track
S011 1986-07-21 Normal 180 Day Track
S010
S009 1986-06-30 Normal 180 Day Track
S008 1986-06-09 Normal 180 Day Track
S007 1986-04-25
S006 1986-04-25
S005 1986-04-25
S004 1986-04-25
S003 1986-01-30
S002 1986-02-24
S001 1986-03-28

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