FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Fluid, Intraocular
PMA: P910071
·
Decision Nov 4, 1994
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Fluid, Intraocular
- Trade Name
- ADATOMED SILICONE OIL OP5000
- PMA Number
- P910071
- Device Class
- FDA Class 3
- Product Code
- LWL
- Generic Name
- Fluid, intraocular
- Regulation Number
- 886.4275
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 4, 1994
- Date Received
- December 16, 1991
- Expedited Review
- Y
- Docket Number
- 95M-0180
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 |
|---|---|---|---|
| LWL | Fluid, Intraocular | FDA class 3 | Ophthalmic |