PMA P860022S055

Device: BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR EXTENDED WEAR
Applicant: Bausch & Lomb
PMA number: P860022
Supplement: S055
Product code: MWL
Decision date: 2003-11-25
Classification: Lens, Contact (rigid Gas Permeable), Extended Wear
Generic name: Lens, contact (rigid gas permeable), extended wear
Approval order statement: APPROVAL FOR COMBINING THE DAILY WEAR AND EXTENDED WEAR LABELING OF THE DEVICE TO BRING THE EXTENDED WEAR LABELING INTO ALIGNMENT WITH THE DAILY WEAR LABELING.

Current openFDA PMA Record#

Device: BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR EXTENDED WEAR
Applicant: Bausch & Lomb
PMA number: P860022
Supplement: S055
Product code: MWL
Generic name: Lens, contact (rigid gas permeable), extended wear
Decision date: 2003-11-25
Decision code: APPR
Date received: 2003-10-28
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR COMBINING THE DAILY WEAR AND EXTENDED WEAR LABELING OF THE DEVICE TO BRING THE EXTENDED WEAR LABELING INTO ALIGNMENT WITH THE DAILY WEAR LABELING.