PMA P030002
- Device
- Trulign® Toric Posterior Chamber Intraocular Lens (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P030002
- Supplement
- S040
- Product code
- NAA
- Decision date
- 2022-04-08
- Generic name
- Lens, intraocular, accommodative
- Approval order statement
- Approval for revised device labeling to describe results of the New Enrollment Study Post Approval Study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Trulign® Toric Posterior Chamber Intraocular Lens (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P030002
- Supplement
- S039
- Product code
- NAA
- Generic name
- Lens, intraocular, accommodative
- Decision date
- 2022-04-08
- Decision code
- APPR
- Date received
- 2021-10-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for revised device labeling to describe results of the New Enrollment Study Post Approval Study (PAS) protocol.