SGP LENS(TM)

FDA Premarket Approval P840055 S015

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

DeviceSGP LENS(TM)
Generic NameLens, Contact (other Material) - Daily
ApplicantTHE LIFESTYLE CO., INC.
Date Received1989-10-30
Decision Date1990-10-02
PMAP840055
SupplementS015
Product CodeHQD 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
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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