SOFT MATE COMFORT DROPS

Accessories, Soft Lens Products

FDA Premarket Approval P800018 S004

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

DeviceSOFT MATE COMFORT DROPS
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1983-05-27
Decision Date1983-10-03
PMAP800018
SupplementS004
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
P800018Original Filing
S020 1995-01-27 Normal 180 Day Track
S019 1992-07-06 Normal 180 Day Track
S018
S017 1990-11-21 Normal 180 Day Track
S016
S015 1990-03-27 Normal 180 Day Track
S014 1990-01-30 Normal 180 Day Track
S013 1989-10-13 Normal 180 Day Track
S012 1989-02-06 Normal 180 Day Track
S011 1987-11-30 Normal 180 Day Track
S010 1987-08-28 Normal 180 Day Track
S009 1987-01-29 Normal 180 Day Track
S008 1986-11-06 Normal 180 Day Track
S007 1986-06-11 Normal 180 Day Track
S006 1985-08-12
S005 1985-01-02
S004 1983-05-27
S003 1982-12-20
S002 1982-10-05
S001 1982-04-13

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