ULTRA CARE (TM) NEUTRALIZING TABLET

FDA Premarket Approval P850088 S029

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

DeviceULTRA CARE (TM) NEUTRALIZING TABLET
Generic NameAccessories, Soft Lens Products
ApplicantADVANCED MEDICAL OPTICS, INC.
Date Received1992-10-28
Decision Date1993-12-15
PMAP850088
SupplementS029
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
P850088Original Filing
S036 1996-08-23 Normal 180 Day Track
S035
S034 1995-06-08 Normal 180 Day Track
S033 1995-05-05 Normal 180 Day Track
S032 1995-03-03 Normal 180 Day Track
S031 1994-01-21 Normal 180 Day Track
S030 1992-11-18 Normal 180 Day Track
S029 1992-10-28 Normal 180 Day Track
S028 1992-05-28 Normal 180 Day Track
S027 1992-05-13 Normal 180 Day Track
S026 1992-03-11 Normal 180 Day Track
S025 1992-03-10 Normal 180 Day Track
S024 1991-11-13 Normal 180 Day Track
S023
S022 1991-02-14 Normal 180 Day Track
S021 1990-11-23 Normal 180 Day Track
S020 1990-10-11 Normal 180 Day Track
S019 1990-08-16 Normal 180 Day Track
S018 1990-05-31 Normal 180 Day Track
S017
S016 1990-05-21 Normal 180 Day Track
S015
S014 1989-12-20 Normal 180 Day Track
S013 1989-12-11 Normal 180 Day Track
S012 1989-11-29 Normal 180 Day Track
S011 1989-11-27 Normal 180 Day Track
S010 1989-11-21 Normal 180 Day Track
S009 1989-11-01 Normal 180 Day Track
S008 1989-10-23 Normal 180 Day Track
S007 1989-09-29 Normal 180 Day Track
S006
S005 1989-01-25 Normal 180 Day Track
S004 1988-09-30 Normal 180 Day Track
S003 1988-04-14 Normal 180 Day Track
S002 1987-10-13 Normal 180 Day Track
S001 1987-03-16 30-Day Supplement

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