SOFTHERM SOL.

Accessories, Soft Lens Products

FDA Premarket Approval N18078 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

DeviceSOFTHERM SOL.
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1985-07-05
Decision Date1985-12-20
PMAN18078
SupplementS017
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
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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