Approval for the clearvisc ophthalmic viscosurgical device (ovd). Clearvisc is indicated for use as a surgical aid in ophthalmic anterior segment procedures including:• extraction of a cataract• implantation of an intraocular lens (iol)
Device | ClearVisc Ophthalmic Viscosurgical (OVD) |
Generic Name | Aid, Surgical, Viscoelastic |
Applicant | Bausch Health |
Date Received | 2020-04-20 |
Decision Date | 2021-03-23 |
PMA | P200025 |
Supplement | S |
Product Code | LZP |
Advisory Committee | Ophthalmic |
Expedited Review | No |
Combination Product | No |
Applicant Address | Bausch Health 400 Somerset Corporate Boulevard bridgewater, NJ 08807 |
Summary: | Summary of Safety and Effectiveness |
Labeling: | Labeling |
Approval Order: | Approval Order |
Supplement Number | Date | Supplement Type |
---|---|---|
P200025 | Original Filing |