TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES

FDA Premarket Approval P890044 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

DeviceTRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES
Generic NameLens, Contact (other Material) - Daily
ApplicantRAND SCIENTIFIC CORP.
Date Received1993-04-29
Decision Date1993-05-27
PMAP890044
SupplementS026
Product CodeHQD 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address RAND SCIENTIFIC CORP. 4135 Northgate Blvd., Suite 9 sacramento, CA 95834

Supplemental Filings

Supplement NumberDateSupplement Type
P890044Original Filing
S027 1993-12-21 Normal 180 Day Track
S026 1993-04-29 Normal 180 Day Track
S025 1993-01-21 Normal 180 Day Track
S024 1992-12-15 Normal 180 Day Track
S023 1992-08-07 Normal 180 Day Track
S022 1992-07-10 Normal 180 Day Track
S021 1992-05-06 Normal 180 Day Track
S020 1992-03-24 Normal 180 Day Track
S019 1992-01-15 Normal 180 Day Track
S018 1991-11-21 Normal 180 Day Track
S017 1991-09-27 Normal 180 Day Track
S016 1991-08-22 Normal 180 Day Track
S015 1991-06-20 Normal 180 Day Track
S014 1991-05-24 Normal 180 Day Track
S013 1991-04-30 Normal 180 Day Track
S012 1991-02-15 Normal 180 Day Track
S011 1991-02-13 Normal 180 Day Track
S010 1990-12-05 30-Day Supplement
S009 1990-09-20 30-Day Supplement
S008 1990-08-09 30-Day Supplement
S007 1990-07-16 Normal 180 Day Track
S006 1990-06-26 Normal 180 Day Track
S005 1990-06-14 Special (immediate Track)
S004 1990-06-04 Normal 180 Day Track
S003 1990-05-16 Normal 180 Day Track
S002 1990-03-29 Normal 180 Day Track
S001 1990-03-29 Normal 180 Day Track

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