SOFTWARE(R) PLUS

FDA Premarket Approval P880079 S012

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

DeviceSOFTWARE(R) PLUS
Generic NameAccessories, Soft Lens Products
ApplicantCIBA VISION CORPORATION
Date Received1993-07-14
Decision Date1994-09-09
PMAP880079
SupplementS012
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address CIBA VISION CORPORATION 11460 Johns Creek Pkwy. duluth, GA 30097

Supplemental Filings

Supplement NumberDateSupplement Type
P880079Original Filing
S013 1995-01-06 Normal 180 Day Track
S012 1993-07-14 Normal 180 Day Track
S011 1991-06-04 Normal 180 Day Track
S010 1991-05-07 Special (immediate Track)
S009
S008 1989-11-07 Normal 180 Day Track
S007 1989-09-21 Normal 180 Day Track
S006
S005 1989-07-27 Normal 180 Day Track
S004 1989-05-22 Normal 180 Day Track
S003 1989-02-03 Normal 180 Day Track
S002
S001 1988-09-13 Normal 180 Day Track

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