- Device
- Bausch + Lomb Ultra (samfilcon A) Contact Lenses Visibility Tinted Soft (hydrophilic) Contact Lenses
- Applicant
- Bausch and Lomb, Inc.,
- PMA number
- P170035
- Supplement
- S012
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2021-04-08
- Decision code
- OK30
- Date received
- 2021-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an alternate supplier of a monomer component for the Ultra® (samfilcon A) product family.