PMA P880098S012

Device: MENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Applicant: Menicon Co, Ltd.
PMA number: P880098
Supplement: S012
Product code: HQD
Decision date: 2002-12-10
Classification: Lens, Contact (other Material) - Daily
Generic name: Lens, contact (other material) - daily
Approval order statement: APPROVAL FOR ALCON UNIQUE-PH MULTI-PURPOSE SOLUTION AS AN ALTERNATE WET SHIPPING SOLUTION FOR THE MENICON SF-P RIGID GAS PERMEABLE CONTACT LENS, LABELING CHANGES TO REFLECT THE USE OF ALCON UNIQUE-PH AS A PACKAGING SOLUTION AND TO UPDATE THE LABELING IN ACCORDANCE WITH RECENTLY APPROVED MENICON RIGID GAS PERMEABLE CONTACT LENS LABELING.

Current openFDA PMA Record#

Device: MENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Applicant: Menicon Co, Ltd.
PMA number: P880098
Supplement: S012
Product code: HQD
Generic name: Lens, contact (other material) - daily
Decision date: 2002-12-10
Decision code: APPR
Date received: 2002-11-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR ALCON UNIQUE-PH MULTI-PURPOSE SOLUTION AS AN ALTERNATE WET SHIPPING SOLUTION FOR THE MENICON SF-P RIGID GAS PERMEABLE CONTACT LENS, LABELING CHANGES TO REFLECT THE USE OF ALCON UNIQUE-PH AS A PACKAGING SOLUTION AND TO UPDATE THE LABELING IN ACCORDANCE WITH RECENTLY APPROVED MENICON RIGID GAS PERMEABLE CONTACT LENS LABELING.