TRI POL

FDA Premarket Approval N18162 S001

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

DeviceTRI POL
Generic NameLenses, Soft Contact, Daily Wear
ApplicantAQUARIUS SOFT LENS, INC.
Date Received1979-05-21
Decision Date1979-06-07
PMAN18162
SupplementS001
Product CodeLPL 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address AQUARIUS SOFT LENS, INC. 1718 Lafayette Rd. indianapolis, IN 46222

Supplemental Filings

Supplement NumberDateSupplement Type
N18162Original Filing
S003 1982-08-31
S002 1979-06-27
S001 1979-05-21

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