SOF FORM (DELTAFILCON A)

FDA Premarket Approval N18146 S006

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

DeviceSOF FORM (DELTAFILCON A)
Generic NameLenses, Soft Contact, Daily Wear
ApplicantUnilens Corp., USA
Date Received1980-11-17
Decision Date1981-11-27
PMAN18146
SupplementS006
Product CodeLPL 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address Unilens Corp., USA 10431 72nd St. North largo, FL 33777

Supplemental Filings

Supplement NumberDateSupplement Type
N18146Original Filing
S007 1981-07-21
S006 1980-11-17
S005 1980-06-11
S004
S003 1980-02-29
S002 1979-05-01
S001 1979-04-24

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