BAUSCH & LOMB SOFLENS 66 & SOFLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES
FDA premarket approval P960022/S008 · decided 2011-03-28
Approval details
- PMA number
- P960022
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BAUSCH & LOMB SOFLENS 66 & SOFLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2011-03-03
- Decision date
- 2011-03-28
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- CHANGE WITH THE SUPPLIER OF THE RAW MATERIAL PROCESSING FOR THE SOFLENS66 AND SOFLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES.
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