STYLE UV40 POSTERIOR CHAMBER LENS

Intraocular Lens

FDA Premarket Approval P830056 S036

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

DeviceSTYLE UV40 POSTERIOR CHAMBER LENS
Classification NameIntraocular Lens
Generic NameIntraocular Lens
ApplicantCARL ZEISS MEDITEC AG
Date Received1988-03-31
Decision Date1988-08-22
PMAP830056
SupplementS036
Product CodeHQL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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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