FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Aid, Surgical, Viscoelastic
PMA: P840064
·
Supplement: S023
·
Decision Mar 25, 2002
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Aid, Surgical, Viscoelastic
- Trade Name
- VISCOAT ORPHTHALMIC VISCOSURGICAL DEVICE
- PMA Number
- P840064
- Supplement Number
- S023
- 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
- March 25, 2002
- Date Received
- February 20, 2002
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR ADDING SYRINGE ASSEMBLY ILLUSTRATIONS AND INSTRUCTIONS TO THE PROVISC PORTION OF THE DUOVISC INSERT TO ENHANCE THE SAFE USE OF THE DEVICE. THE PROVISC SYRINGE ASSEMBLY INSTRUCTIONS WILL STANDARDIZE INSTRUCTIONS WITHIN THE DUOVISC INSERT.
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 |