HYDROCURVE

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval N17752 S021

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 Received1984-09-14
Decision Date1986-08-13
PMAN17752
SupplementS021
Product CodeLPL
Advisory CommitteeOphthalmic
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.