SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM

Accessories, Soft Lens Products

FDA Premarket Approval P840066 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(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1988-02-26
Decision Date1988-08-08
PMAP840066
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
P840066Original Filing
S034 1996-11-20 Normal 180 Day Track
S033 1995-01-27 Normal 180 Day Track
S032 1991-11-06 Normal 180 Day Track
S031 1991-10-22 Normal 180 Day Track
S030 1991-10-08 Normal 180 Day Track
S029 1991-10-03 Normal 180 Day Track
S028 1991-07-03 Normal 180 Day Track
S027 1990-11-21 Normal 180 Day Track
S026 1990-06-29 Normal 180 Day Track
S025
S024 1990-03-27 Normal 180 Day Track
S023 1990-02-07 Normal 180 Day Track
S022 1990-01-30 Normal 180 Day Track
S021 1989-10-12 Normal 180 Day Track
S020 1989-09-21 Normal 180 Day Track
S019 1989-09-07 Normal 180 Day Track
S018 1989-02-06 Normal 180 Day Track
S017
S016
S015 1988-07-28 Normal 180 Day Track
S014 1988-06-16 Normal 180 Day Track
S013 1988-06-09 Normal 180 Day Track
S012 1988-02-26 Normal 180 Day Track
S011 1988-02-09 Normal 180 Day Track
S010 1988-02-09 Normal 180 Day Track
S009 1987-11-19 Normal 180 Day Track
S008 1987-10-20 Normal 180 Day Track
S007 1987-07-09 Normal 180 Day Track
S006 1987-05-15 Normal 180 Day Track
S005 1987-04-24 Normal 180 Day Track
S004 1986-12-15 Normal 180 Day Track
S003
S002 1986-11-06 Normal 180 Day Track
S001

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