PMA P980006S026
- Device
- PureVision (balafilcon A) Visibility Tinted Contact Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P980006
- Supplement
- S026
- Product code
- LPM
- Decision date
- 2018-03-29
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Change to the tear strength specification for the PureVision (balafilcon A) product family.
Current openFDA PMA Record#
- Device
- PureVision (balafilcon A) Visibility Tinted Contact Lens
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P980006
- Supplement
- S026
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2018-03-29
- Decision code
- OK30
- Date received
- 2017-12-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the tear strength specification for the PureVision (balafilcon A) product family.