GAS PERMEABLE REGIMEN

Accessories, Soft Lens Products

FDA Premarket Approval P820053 S007

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 Received1987-01-05
Decision Date1988-04-04
PMAP820053
SupplementS007
Product CodeLPN
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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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