FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Aid, Surgical, Viscoelastic
PMA: P840064
·
Supplement: S089
·
Decision Feb 10, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
Research PMA P840064 in seconds
The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Aid, Surgical, Viscoelastic
- Trade Name
- VISCOAT Ophthalmic Viscosurgical Device
- PMA Number
- P840064
- Supplement Number
- S089
- Device Class
- FDA Class 3
- Product Code
- LZP
- Generic Name
- AID, SURGICAL, VISCOELASTIC
- Regulation Number
- 886.4275
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 10, 2026
- Date Received
- June 5, 2025
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
approval for adding a new fill volume (0.75 mL) of an ophthalmic viscosurgical device (OVD) into a 1 mL syringe. This would be produced at the LifeCore Biomedical site.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZP | Aid, Surgical, Viscoelastic | FDA class 3 | Ophthalmic |