FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Fluid, Intraocular
PMA: P950008
·
Supplement: S023
·
Decision Jun 3, 2024
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Fluid, Intraocular
- Trade Name
- Silikon 1000
- PMA Number
- P950008
- Supplement Number
- S023
- Device Class
- FDA Class 3
- Product Code
- LWL
- Generic Name
- Fluid, intraocular
- Regulation Number
- 886.4275
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- June 3, 2024
- Date Received
- May 6, 2024
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Add Alcon Laboratories, Fort Worth North Manufacturing laboratory as an approved laboratory to perform testing of Ethanol using the same method, in addition to the approved contract laboratories.
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 |