AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR

Lens, Contact (polymethylmethacrylate)

FDA Premarket Approval P830070 S026

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

DeviceAIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
Classification NameLens, Contact (polymethylmethacrylate)
Generic NameLens, Contact (polymethylmethacrylate)
ApplicantCIBA VISION CORPORATION
Date Received1988-09-08
Decision Date1988-09-22
PMAP830070
SupplementS026
Product CodeHPX
Advisory CommitteeOphthalmic
Supplement Type30-Day Supplement
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address CIBA VISION CORPORATION 11460 Johns Creek Parkway duluth, GA 30097

Supplemental Filings

Supplement NumberDateSupplement Type
P830070Original Filing
S033 1989-09-11 Normal 180 Day Track
S032 1989-02-09 Normal 180 Day Track
S031 1988-12-13 Normal 180 Day Track
S030 1988-11-15 30-Day Supplement
S029 1988-11-08 30-Day Supplement
S028 1988-10-28 30-Day Supplement
S027 1988-09-12 30-Day Supplement
S026 1988-09-08 30-Day Supplement
S025 1988-09-06 30-Day Supplement
S024 1988-08-26 Normal 180 Day Track
S023 1988-08-15 30-Day Supplement
S022 1988-08-11 30-Day Supplement
S021 1988-08-01 30-Day Supplement
S020 1988-07-22 30-Day Supplement
S019 1988-07-15 30-Day Supplement
S018 1988-07-08 30-Day Supplement
S017 1988-07-05 30-Day Supplement
S016 1988-06-17 30-Day Supplement
S015 1988-04-11 30-Day Supplement
S014 1988-04-05 30-Day Supplement
S013 1988-03-23 Normal 180 Day Track
S012 1988-03-01 Normal 180 Day Track
S011 1988-02-29 Normal 180 Day Track
S010 1988-02-19 Normal 180 Day Track
S009 1988-02-03 Normal 180 Day Track
S008 1988-01-27 Normal 180 Day Track
S007 1988-01-06 30-Day Supplement
S006 1987-11-09 30-Day Supplement
S005 1987-07-01 30-Day Supplement
S004 1986-08-01 Panel Track
S003 1985-11-04
S002 1985-01-28
S001 1985-01-11 Normal 180 Day Track

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