ALGES(TM) (HEFILCON A) CONTACT LENS

FDA Premarket Approval P850002 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

DeviceALGES(TM) (HEFILCON A) CONTACT LENS
Generic NameLenses, Soft Contact, Daily Wear
ApplicantUnilens Corp., USA
Date Received1991-02-01
Decision Date1991-06-12
PMAP850002
SupplementS006
Product CodeLPL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Unilens Corp., USA 10431 72nd St. North p.o. Box 2530 largo, FL 34647

Supplemental Filings

Supplement NumberDateSupplement Type
P850002Original Filing
S009 1991-12-13 Normal 180 Day Track
S008 1991-12-13 Normal 180 Day Track
S007 1991-02-22 Normal 180 Day Track
S006 1991-02-01 Normal 180 Day Track
S005 1989-02-17 Normal 180 Day Track
S004
S003 1988-10-05 Normal 180 Day Track
S002 1988-01-20 Normal 180 Day Track
S001 1985-08-13

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