FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Aid, Surgical, Viscoelastic
PMA: P880031
·
Decision Aug 10, 1989
Classifications
1
FEI Numbers
27
Registration Numbers
27
Basic Information
- Device Name
- Aid, Surgical, Viscoelastic
- Trade Name
- VITRAX SODIUM HYALURONATE
- PMA Number
- P880031
- 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- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- August 10, 1989
- Date Received
- April 18, 1988
- Expedited Review
- N
- Docket Number
- 89M-0344
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 |