FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Fluid, Intraocular
PMA: P910071
·
Supplement: S001
·
Decision Nov 30, 1994
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Fluid, Intraocular
- Trade Name
- ADATO SIL 5000
- PMA Number
- P910071
- 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
- November 30, 1994
- Date Received
- November 18, 1994
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
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 |