SOFT MATE COMFORT DROPS

FDA Premarket Approval P800018 S017

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
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1990-11-21
Decision Date1994-04-13
PMAP800018
SupplementS017
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
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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