GAS PERMEABLE REGIMEN

Accessories, Soft Lens Products

FDA Premarket Approval P820053 S001

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

DeviceGAS PERMEABLE REGIMEN
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1984-03-22
Decision Date1986-04-23
PMAP820053
SupplementS001
Product CodeLPN
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement NumberDateSupplement Type
P820053Original Filing
S025 1997-01-17 Normal 180 Day Track
S024
S023 1995-01-27 Normal 180 Day Track
S022 1992-12-11 Normal 180 Day Track
S021 1992-10-26 Normal 180 Day Track
S020 1992-02-03 Normal 180 Day Track
S019
S018 1990-11-21 Normal 180 Day Track
S017
S016 1990-03-27 Normal 180 Day Track
S015 1990-01-30 Normal 180 Day Track
S014 1989-10-12 Normal 180 Day Track
S013 1989-09-07 Normal 180 Day Track
S012 1989-05-09 Normal 180 Day Track
S011 1989-03-29 Normal 180 Day Track
S010 1988-09-19 Normal 180 Day Track
S009 1987-04-13 Normal 180 Day Track
S008 1987-01-13 Normal 180 Day Track
S007 1987-01-05 Normal 180 Day Track
S006 1986-11-06 30-Day Supplement
S005
S004 1986-01-21
S003 1985-08-12
S002 1985-05-15
S001 1984-03-22

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