SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH

Accessories, Soft Lens Products

FDA Premarket Approval P820040 S009

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
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantCIBA VISION CARE
Date Received1985-10-15
Decision Date1987-07-30
PMAP820040
SupplementS009
Product CodeLPN
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
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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