FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Aid, Surgical, Viscoelastic
PMA: P840064
·
Supplement: S091
·
Decision Oct 3, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Aid, Surgical, Viscoelastic
- Trade Name
- VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System; DISCOVISC Ophthalmic Viscosurgical D
- PMA Number
- P840064
- Supplement Number
- S091
- Device Class
- FDA Class 3
- Product Code
- LZP
- Generic Name
- AID, SURGICAL, VISCOELASTIC
- Regulation Number
- 886.4275
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- October 3, 2025
- Date Received
- September 8, 2025
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
updating the cannula incoming inspections procedures for the VISCOAT Ophthalmic Viscosurgical Device (OVD), DUOVISC Ophthalmic Viscoelastic System, DISCOVISC Ophthalmic Viscosurgical Device, and PROVISC Ophthalmic Viscosurgical Device
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 |