SOFTLENS CLEANING & DISINFECTING SOLN.

FDA Premarket Approval N17786 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

DeviceSOFTLENS CLEANING & DISINFECTING SOLN.
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1988-04-14
Decision Date1988-08-31
PMAN17786
SupplementS017
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
N17786Original Filing
S025 1995-06-08 Normal 180 Day Track
S024 1995-05-05 Normal 180 Day Track
S023
S022 1989-09-29 Normal 180 Day Track
S021 1989-06-15 Normal 180 Day Track
S020
S019
S018
S017 1988-04-14 Normal 180 Day Track
S016 1988-01-25 Normal 180 Day Track
S015 1987-03-16 30-Day Supplement
S014 1984-06-04
S013 1984-04-23
S012
S011 1982-09-29
S010 1982-06-07
S009 1982-05-06
S008 1982-04-12
S007 1982-03-29
S006 1982-03-04
S005 1981-07-28
S004 1981-05-19
S003 1981-02-12
S002 1980-11-07
S001 1980-11-07

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