FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Fluid, Intraocular
PMA: P950018
·
Decision Feb 29, 1996
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Fluid, Intraocular
- Trade Name
- PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)
- PMA Number
- P950018
- 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
- February 29, 1996
- Date Received
- April 28, 1995
- Expedited Review
- Y
- Docket Number
- 96M-0233
Advisory Committee Statement
APPROVAL FOR PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID) THIS DEVICE, A PERFLUOROCARBON LIQUID, IS AN INTRAOPERATIVE TOOL
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 |