SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH

FDA Premarket Approval P820040 S019

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

DeviceSEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH
Generic NameAccessories, Soft Lens Products
ApplicantCIBA VISION CARE
Date Received1988-01-27
Decision Date1988-05-06
PMAP820040
SupplementS019
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeSpecial (immediate Track)
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CIBA VISION CARE 11460 Johns Creek Pkwy. duluth, GA 30136-1518

Supplemental Filings

Supplement NumberDateSupplement Type
P820040Original Filing
S033 1995-07-27 Normal 180 Day Track
S032 1994-09-08 Normal 180 Day Track
S031 1991-11-05 Normal 180 Day Track
S030 1991-09-03 Normal 180 Day Track
S029 1990-11-01 Normal 180 Day Track
S028
S027 1990-05-09 Normal 180 Day Track
S026 1990-03-02 Normal 180 Day Track
S025 1989-08-29 Normal 180 Day Track
S024
S023 1989-01-26 Normal 180 Day Track
S022 1988-12-08 Normal 180 Day Track
S021 1988-11-21 Normal 180 Day Track
S020 1988-04-05 Normal 180 Day Track
S019 1988-01-27 Special (immediate Track)
S018
S017 1987-09-08 Normal 180 Day Track
S016 1987-08-28 Normal 180 Day Track
S015 1987-07-16 Normal 180 Day Track
S014 1987-04-13 Normal 180 Day Track
S013 1987-04-01 Normal 180 Day Track
S012 1986-12-03 30-Day Supplement
S011 1986-06-27 Normal 180 Day Track
S010 1986-02-26
S009 1985-10-15 Normal 180 Day Track
S008
S007 1985-09-30
S006 1985-05-20
S005 1985-05-02
S004 1984-08-30
S003 1984-07-17
S002 1984-01-03
S001 1983-03-24

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