RIGID GAS PERMEABLE CONTACT LENSES

FDA Premarket Approval P840055 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

DeviceRIGID GAS PERMEABLE CONTACT LENSES
Generic NameLens, Contact (other Material) - Daily
ApplicantTHE LIFESTYLE CO., INC.
Date Received1990-11-08
Decision Date1990-12-12
PMAP840055
SupplementS021
Product CodeHQD 
Advisory CommitteeOphthalmic
Supplement Type30-Day Supplement
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address THE LIFESTYLE CO., INC. 712 Ginesi Dr. morganville, NJ 07751

Supplemental Filings

Supplement NumberDateSupplement Type
P840055Original Filing
S032 1993-08-24 Normal 180 Day Track
S031 1993-05-11 Normal 180 Day Track
S030 1992-11-30 Normal 180 Day Track
S029 1992-11-06 Normal 180 Day Track
S028 1992-10-23 Normal 180 Day Track
S027 1992-09-22 Normal 180 Day Track
S026 1992-08-19 Normal 180 Day Track
S025 1992-03-04 Normal 180 Day Track
S024 1991-12-23 Normal 180 Day Track
S023 1991-07-16 Normal 180 Day Track
S022 1991-04-11 Normal 180 Day Track
S021 1990-11-08 30-Day Supplement
S020 1990-10-04 Normal 180 Day Track
S019 1990-09-17 30-Day Supplement
S018 1990-06-11 Special (immediate Track)
S017 1990-02-14 Normal 180 Day Track
S016 1989-12-26 Normal 180 Day Track
S015 1989-10-30 Normal 180 Day Track
S014 1989-05-15 Normal 180 Day Track
S013 1989-02-17 Normal 180 Day Track
S012 1988-12-09 Normal 180 Day Track
S011 1988-09-27 30-Day Supplement
S010 1988-04-01 30-Day Supplement
S009 1988-01-12 Normal 180 Day Track
S008 1987-10-27 30-Day Supplement
S007 1987-05-15 30-Day Supplement
S006 1987-03-12 30-Day Supplement
S005 1987-02-09 Normal 180 Day Track
S004 1987-01-14 30-Day Supplement
S003 1986-12-03 30-Day Supplement
S002 1986-11-18 Normal 180 Day Track
S001 1986-08-28 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00830002002012 P840055 001
00830002001015 P840055 009

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