SOFTLENS CLEANING & DISINFECTING SOLN.

FDA Premarket Approval N17786 S010

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 Received1982-06-07
Decision Date1982-09-14
PMAN17786
SupplementS010
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
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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