LENS FRESH(TM) LUBRICATING & REWETTING SOLN

FDA Premarket Approval N18020 S031

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

DeviceLENS FRESH(TM) LUBRICATING & REWETTING SOLN
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1989-10-26
Decision Date1990-01-22
PMAN18020
SupplementS031
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement NumberDateSupplement Type
N18020Original Filing
S041 1995-06-08 Normal 180 Day Track
S040 1995-05-30 Normal 180 Day Track
S039 1995-05-05 Normal 180 Day Track
S038 1993-03-19 Normal 180 Day Track
S037 1990-10-31 Normal 180 Day Track
S036 1990-10-09 Normal 180 Day Track
S035 1990-09-12 Normal 180 Day Track
S034 1990-07-12 Normal 180 Day Track
S033 1990-01-23 Normal 180 Day Track
S032 1989-12-04 Normal 180 Day Track
S031 1989-10-26 Normal 180 Day Track
S030 1989-09-29 Normal 180 Day Track
S029 1989-05-31 Normal 180 Day Track
S028 1989-04-03 Normal 180 Day Track
S027 1989-01-06 Normal 180 Day Track
S026 1988-05-27 Normal 180 Day Track
S025 1988-04-14 Normal 180 Day Track
S024 1988-01-25 Normal 180 Day Track
S023 1987-10-20 Normal 180 Day Track
S022 1987-03-16 30-Day Supplement
S021
S020 1987-01-27 Normal 180 Day Track
S019 1984-09-05
S018
S017 1984-06-04
S016 1984-04-23
S015 1983-11-01
S014 1982-12-07
S013 1982-04-30
S012 1982-04-12
S011 1981-06-22
S010 1980-12-15
S009
S008
S007 1980-05-05
S006 1980-09-23
S005 1980-09-23
S004 1980-01-15
S003 1980-01-02
S002 1979-08-17
S001

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