AQUAFLEX[TETRAFILCON A] CONTACT LENSES/SHELF LIFE

FDA Premarket Approval P880101 S004

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

DeviceAQUAFLEX[TETRAFILCON A] CONTACT LENSES/SHELF LIFE
Generic NameLenses, Soft Contact, Daily Wear
ApplicantUNILENS CORPORATION USA
Date Received1989-10-02
Decision Date1990-09-14
Notice Date1990-11-02
PMAP880101
SupplementS004
Product CodeLPL 
Docket Number90M-0317
Advisory CommitteeOphthalmic
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address UNILENS CORPORATION USA 10431 72nd Street North largo, FL 33777

Supplemental Filings

Supplement NumberDateSupplement Type
P880101Original Filing
S006 1994-05-03 30-Day Supplement
S005 1991-07-03 Normal 180 Day Track
S004 1989-10-02 Panel Track
S003 1989-09-18 Normal 180 Day Track
S002 1989-09-14 Normal 180 Day Track
S001

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