ClearVisc Ophthalmic Viscosurgical (OVD)

FDA Premarket Approval P200025

Pre-market Approval Supplement Details

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)

DeviceClearVisc Ophthalmic Viscosurgical (OVD)
Generic NameAid, Surgical, Viscoelastic
ApplicantBausch Health
Date Received2020-04-20
Decision Date2021-03-23
PMAP200025
SupplementS
Product CodeLZP 
Advisory CommitteeOphthalmic
Expedited ReviewNo
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

Supplemental Filings

A PHP Error was encountered

Severity: Notice

Message: Undefined offset: 0

Filename: fda.report/pma_item.php

Line Number: 133

Backtrace:

File: /var/www/fda.report/pma_item.php
Line: 133
Function: _error_handler

Supplement NumberDateSupplement Type
P200025Original Filing

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.