FDA Approved
Existing Device (Modification)
Pathway: PMA
Healon EndoCoat PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hya
Applicant:
Johnson & Johnson Surgical Vision, Inc.
JNJ
Statutory Profile
Legal Standard:
Reasonable assurance of safety and effectiveness (Section 515 FD&C Act)
Product Code:
LZP
Review Panel:
Ophthalmic
21 CFR Regulation:
Unspecified
Review Velocity Metrics
Date Received:
2026-07-27
Decision Date:
2026-10-30
Total Review Duration:
95 calendar days (95 days)
Official FDA Research Backlinks
Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:
Identified Contacts & Correspondents
Rosanne Melikian
Role: OFFICIAL_CORRESPONDENT
📞 1-714-3138856-x
Rosanne Melikian
Role: US_AGENT
📞 714-3138856
✉️ RegulatoryImplantsMailBox01@its.jnj.com
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