FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Fluid, Intraocular
PMA: P950008
·
Supplement: S003
·
Decision Jan 23, 2002
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Fluid, Intraocular
- Trade Name
- SILIKON 1000
- PMA Number
- P950008
- Supplement Number
- S003
- 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
- January 23, 2002
- Date Received
- October 4, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MODIFICATION OF THE MOLECULAR WEIGHT RANGE SPECIFICATION FOR SILIKON 1000 FROM 36,000 - 48,000 DALTON TO 32,850 - 47,000 DALTON.
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 |