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

Lens, Contact (polymethylmethacrylate)

FDA Premarket Approval P830070 S017

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 Received1988-07-05
Decision Date1988-09-09
PMAP830070
SupplementS017
Product CodeHPX
Advisory CommitteeOphthalmic
Supplement Type30-Day Supplement
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
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

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