SOFT MATE(R) PREMIXED PROTEIN REMOVER SOLUTION

Accessories, Soft Lens Products

FDA Premarket Approval P810017 S003

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(R) PREMIXED PROTEIN REMOVER SOLUTION
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1984-01-05
Decision Date1986-10-16
PMAP810017
SupplementS003
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
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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