PMA P980006
- Device
- Pure Vision (balafilcon A) Visibility Tinted Soft (hydrophillic) Contact Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P980006
- Supplement
- S035
- Product code
- LPM
- Decision date
- 2025-03-17
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- use of a raw material supplier at the Bausch & Lomb Rochester, New York manufacturing facility
Current openFDA PMA Record#
- Device
- Pure Vision (balafilcon A) Visibility Tinted Soft (hydrophillic) Contact Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P980006
- Supplement
- S037
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2025-03-17
- Decision code
- OK30
- Date received
- 2025-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- use of a raw material supplier at the Bausch & Lomb Rochester, New York manufacturing facility