- Device
- BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P960022
- Supplement
- S007
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2011-02-18
- Decision code
- APPR
- Date received
- 2010-11-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A NAME CHANGE TO THE CURRENTLY MARKETED BAUSCH & LOMB SOFLENS 66 TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES. THE PROPOSED NAME FOR THE DEVICE IS BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENSES.