- Device
- Bausch + Lomb PureVision (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P980006
- Supplement
- S030
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2020-09-28
- Decision code
- OK30
- Date received
- 2020-09-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of an additional manufacturer of a raw material for Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses and Bausch + Lomb PureVision (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses.