FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Fluid, Intraocular
PMA: P950018
·
Supplement: S028
·
Decision Jun 11, 2024
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Fluid, Intraocular
- Trade Name
- Perfluoron
- PMA Number
- P950018
- Supplement Number
- S028
- 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 11, 2024
- Date Received
- May 14, 2024
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
change to the endotoxin test from Limulus Amebocyte Lysate (LAL) gel-clot method to Kinetic Turbidimetric (KT)/Chromogenic method and the respective releasing specification of the finished Perfluoron product
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 |