TRESOFT SOFT CONTACT LENSE

FDA Premarket Approval N17855 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

DeviceTRESOFT SOFT CONTACT LENSE
Generic NameLenses, Soft Contact, Daily Wear
ApplicantCIBA VISION CARE
Date Received1979-10-04
Decision Date1980-05-05
PMAN17855
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
N17855Original Filing
S006 1987-11-24 Normal 180 Day Track
S005 1986-08-13 Normal 180 Day Track
S004 1983-11-04
S003 1982-05-10
S002 1979-10-04
S001 1979-06-24

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