PMA P170035S005
- Device
- Ultra (samfilcon A) Contact Lens
- Applicant
- Bausch and Lomb, Inc.,
- Product code
- LPM
- Decision date
- 2019-10-10
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Approval to remove the prismatic error test method and acceptance criteria from the finished product specifications.
Current openFDA PMA Record#
- Device
- Ultra (samfilcon A) Contact Lens
- Applicant
- Bausch and Lomb, Inc.,
- PMA number
- P170035
- Supplement
- S005
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2019-10-10
- Decision code
- APPR
- Date received
- 2019-07-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to remove the prismatic error test method and acceptance criteria from the finished product specifications.