- Device
- PureVision (balafilcon A) Contact Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P980006
- Supplement
- S032
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2021-08-27
- Decision code
- APPR
- Date received
- 2021-06-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to remove the Sagittal Depth measurement acceptance criteria from the finished product specifications for PureVision (balafilcon A) Contact Lens.