HYDROCURVE

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval N17752 S035

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

DeviceHYDROCURVE
Classification NameLenses, Soft Contact, Daily Wear
Generic NameLenses, Soft Contact, Daily Wear
ApplicantCIBA VISION CORPORATION
Date Received1994-10-06
Decision Date1994-11-09
PMAN17752
SupplementS035
Product CodeLPL
Advisory CommitteeOphthalmic
Supplement Type30-Day Supplement
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address CIBA VISION CORPORATION 11460 Johns Creek Parkway duluth, GA 30097

Supplemental Filings

Supplement NumberDateSupplement Type
N17752Original Filing
S038 2001-03-30 Normal 180 Day Track
S037 1999-12-23 Normal 180 Day Track
S036 1995-05-15 Normal 180 Day Track
S035 1994-10-06 30-Day Supplement
S034 1989-08-08 Normal 180 Day Track
S033 1989-07-24 Normal 180 Day Track
S032 1989-05-17 Normal 180 Day Track
S031 1987-12-17 Normal 180 Day Track
S030 1987-09-15 Special (immediate Track)
S029 1987-03-03 30-Day Supplement
S028 1987-01-12 Normal 180 Day Track
S027 1987-01-05 Normal 180 Day Track
S026 1986-04-29
S025 1985-11-04
S024 1985-05-20
S023 1985-02-04
S022 1985-02-04
S021 1984-09-14
S020 1984-08-24
S019 1983-10-26
S018 1983-10-06
S017 1983-06-24
S016 1983-06-13
S015 1982-07-07
S014 1981-04-14
S013 1981-04-06
S012 1981-04-07
S011
S010 1980-11-04
S009 1980-06-06
S008 1980-03-26
S007 1980-02-15
S006 1980-01-08
S005 1979-08-10
S004 1979-08-10
S003 1979-08-03
S002
S001 1978-11-16

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