C-65 DAILY CONTACT LENS CLEANER

FDA Premarket Approval P790024 S020

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

DeviceC-65 DAILY CONTACT LENS CLEANER
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1989-08-03
Decision Date1989-09-18
PMAP790024
SupplementS020
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement NumberDateSupplement Type
P790024Original Filing
S025 1995-06-08 Normal 180 Day Track
S024 1995-05-05 Normal 180 Day Track
S023 1992-09-11 Normal 180 Day Track
S022 1989-09-29 Normal 180 Day Track
S021
S020 1989-08-03 Normal 180 Day Track
S019 1989-02-17 Normal 180 Day Track
S018 1988-05-20 Normal 180 Day Track
S017 1988-04-14 Normal 180 Day Track
S016 1987-09-16 Normal 180 Day Track
S015 1987-03-16 30-Day Supplement
S014 1987-01-20 Normal 180 Day Track
S013 1986-12-03 30-Day Supplement
S012 1986-08-14 Normal 180 Day Track
S011
S010 1985-04-23
S009 1984-08-27
S008 1984-08-08
S007 1984-06-04
S006 1984-04-23
S005 1982-10-01
S004 1982-04-29
S003 1982-04-20
S002 1982-04-20
S001 1981-03-11

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