SOFTMATE SOLUTION

Accessories, Soft Lens Products

FDA Premarket Approval N18073 S009

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

DeviceSOFTMATE SOLUTION
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1986-06-11
Decision Date1986-10-27
PMAN18073
SupplementS009
Product CodeLPN
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement NumberDateSupplement Type
N18073Original Filing
S024 1995-01-27 Normal 180 Day Track
S023 1992-10-26 Normal 180 Day Track
S022 1990-11-21 Normal 180 Day Track
S021
S020 1990-03-27 Normal 180 Day Track
S019 1990-01-30 Normal 180 Day Track
S018 1989-10-13 Normal 180 Day Track
S017 1987-11-30 Normal 180 Day Track
S016
S015 1987-01-29 Normal 180 Day Track
S014 1986-11-07 30-Day Supplement
S013 1986-11-06 30-Day Supplement
S012 1986-09-18 Normal 180 Day Track
S011 1986-09-02 Normal 180 Day Track
S010
S009 1986-06-11 Normal 180 Day Track
S008 1985-08-12
S007 1985-08-12
S006 1985-04-08
S005
S004 1983-06-07
S003 1982-04-13
S002 1980-02-05
S001 1979-06-23

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