SOFT MATE WEEKLY CLEANING SOLUTION

Accessories, Soft Lens Products

FDA Premarket Approval P810017 S012

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 WEEKLY CLEANING SOLUTION
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1987-01-29
Decision Date1987-03-26
PMAP810017
SupplementS012
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
P810017Original Filing
S020 1990-11-21 Normal 180 Day Track
S019
S018 1990-03-27 Normal 180 Day Track
S017 1990-01-30 Normal 180 Day Track
S016 1989-10-12 Normal 180 Day Track
S015 1989-09-07 Normal 180 Day Track
S014 1987-12-22 Special (immediate Track)
S013 1987-08-14 Normal 180 Day Track
S012 1987-01-29 Normal 180 Day Track
S011 1986-11-06 30-Day Supplement
S010
S009
S008 1986-06-11 Normal 180 Day Track
S007 1985-08-12
S006 1985-08-12
S005 1985-03-04
S004 1984-05-02
S003 1984-01-05
S002 1983-02-01
S001 1982-03-09

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