PMA P830037S040

Device: DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC AND SPHERICAL CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P830037
Supplement: S040
Product code: LPM
Decision date: 1997-05-15
Generic name: Lenses, soft contact, extended wear
Approval order statement: APPROVAL TO ADD AN ULTRA VIOLET ABSORBER TO THE CLEAR AND LITETINE LATHE CUT POLYMER RODS FOR THE SUBJECT DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES DURASOFT(R)3 AND DURASOFT(R)3 UV (PHEMFILCON A) SPHERICAL AND OPTIFIT(R) TORIC CLEAR, LITETINT, COLORS, AND COLOR COMPLEMENTS SOFT (HYDROPHILIC) CONTACT LENSES (LATHE CUT) FOR EXTENDED WEAR WITH NO CHANGE IN THE CURRENTLY APPROVED INDICATIONS FOR USE.

Current openFDA PMA Record#

Device: DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC AND SPHERICAL CONTACT LENSES
Applicant: Alcon Laboratories, Inc.
PMA number: P830037
Supplement: S040
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 1997-05-15
Decision code: APPR
Date received: 1996-12-18
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO ADD AN ULTRA VIOLET ABSORBER TO THE CLEAR AND LITETINE LATHE CUT POLYMER RODS FOR THE SUBJECT DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES DURASOFT(R)3 AND DURASOFT(R)3 UV (PHEMFILCON A) SPHERICAL AND OPTIFIT(R) TORIC CLEAR, LITETINT, COLORS, AND COLOR COMPLEMENTS SOFT (HYDROPHILIC) CONTACT LENSES (LATHE CUT) FOR EXTENDED WEAR WITH NO CHANGE IN THE CURRENTLY APPROVED INDICATIONS FOR USE.