PMA P170035S013
- Device
- Ultra (samfilcon A) Contact Lens
- Applicant
- Bausch and Lomb, Inc.,
- PMA number
- P170035
- Supplement
- S013
- Product code
- LPM
- Decision date
- 2021-08-27
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Approval to remove the Sagittal Depth measurement acceptance criteria from the finished product specifications for Ultra (samfilcon A) Contact Lens.
Current openFDA PMA Record#
- Device
- Ultra (samfilcon A) Contact Lens
- Applicant
- Bausch and Lomb, Inc.,
- PMA number
- P170035
- Supplement
- S013
- 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 Ultra (samfilcon A) Contact Lens.