SOFTCON BANDAGE LENS

FDA Premarket Approval N17375 S002

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

DeviceSOFTCON BANDAGE LENS
Generic NameLenses, Soft Contact, Daily Wear
ApplicantCIBA VISION CARE
Date Received1979-11-14
Decision Date1980-03-18
PMAN17375
SupplementS002
Product CodeLPL 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address CIBA VISION CARE 11460 Johns Creek Pkwy. duluth, GA 30136-1518

Supplemental Filings

Supplement NumberDateSupplement Type
N17375Original Filing
S011 1986-03-18
S010 1986-03-04
S009
S008
S007 1985-01-17
S006
S005
S004 1980-04-17
S003
S002 1979-11-14
S001 1979-07-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.