FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Fluid, Intraocular
PMA: P950008
·
Supplement: S001
·
Decision Jul 11, 2000
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Fluid, Intraocular
- Trade Name
- SILIKON 1000
- PMA Number
- P950008
- Supplement Number
- S001
- 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
- July 11, 2000
- Date Received
- June 19, 2000
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A MODIFICATION TO THE MOLECULAR WEIGHT SPECIFICATION RANGE FROM 38,000-48,000 DALTONS TO 36,000-48,000 DALTONS.
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 |