SOFTSITE (HEFILCON A) CONTACT LENS

FDA Premarket Approval N17793 S014

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

DeviceSOFTSITE (HEFILCON A) CONTACT LENS
Generic NameLenses, Soft Contact, Daily Wear
ApplicantUNILENS CORPORATION USA
Date Received1987-04-08
Decision Date1987-10-05
PMAN17793
SupplementS014
Product CodeLPL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address UNILENS CORPORATION USA 10431 72nd Street North largo, FL 33777

Supplemental Filings

Supplement NumberDateSupplement Type
N17793Original Filing
S014 1987-04-08 Normal 180 Day Track
S013 1987-04-08 Normal 180 Day Track
S012 1986-09-03 Normal 180 Day Track
S011 1985-09-16
S010 1985-09-16
S009 1985-08-19
S008 1983-11-04
S007
S006 1983-07-11
S005 1982-01-08
S004 1980-11-06
S003 1980-05-28
S002
S001 1979-10-22

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