SOFTHERM SOL.

Accessories, Soft Lens Products

FDA Premarket Approval N18078 S040

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

DeviceSOFTHERM SOL.
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1988-07-28
Decision Date1988-10-28
PMAN18078
SupplementS040
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
N18078Original Filing
S049 1995-01-27 Normal 180 Day Track
S048 1992-11-19 Normal 180 Day Track
S047 1990-11-21 Normal 180 Day Track
S046
S045 1990-03-27 Normal 180 Day Track
S044 1989-10-12 Normal 180 Day Track
S043 1989-09-07 Normal 180 Day Track
S042 1989-07-31 Normal 180 Day Track
S041 1989-05-19 Normal 180 Day Track
S040 1988-07-28 Normal 180 Day Track
S039 1988-06-16 Normal 180 Day Track
S038 1988-01-05 Normal 180 Day Track
S037 1987-11-30 Normal 180 Day Track
S036 1987-11-30 Normal 180 Day Track
S035 1987-10-22 Normal 180 Day Track
S034 1987-09-15 Normal 180 Day Track
S033 1987-07-09 Normal 180 Day Track
S032 1987-05-27 Normal 180 Day Track
S031 1987-05-15 Normal 180 Day Track
S030 1987-01-29 Normal 180 Day Track
S029 1986-11-07 30-Day Supplement
S028 1986-08-22 Normal 180 Day Track
S027 1986-07-02 Normal 180 Day Track
S026 1986-06-11 Normal 180 Day Track
S025 1986-05-20 Normal 180 Day Track
S024 1986-05-20 Normal 180 Day Track
S023 1986-03-24
S022 1986-03-13
S021 1986-01-21
S020 1985-12-13
S019 1985-04-09
S018 1985-07-23
S017 1985-07-05
S016 1985-04-08
S015 1985-01-23
S014 1985-01-02
S013 1984-08-27
S012 1984-05-03
S011
S010 1984-01-04
S009 1983-05-16
S008 1983-04-28
S007 1982-06-17
S006 1982-04-13
S005 1981-04-13
S004 1981-04-06
S003 1980-07-24
S002 1979-08-09
S001 1979-07-31

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