FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Fluid, Intraocular
PMA: P950018
·
Supplement: S015
·
Decision Mar 30, 2012
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Fluid, Intraocular
- Trade Name
- PERFLUORON
- PMA Number
- P950018
- Supplement Number
- S015
- 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
- March 30, 2012
- Date Received
- January 30, 2012
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MINOR LABELING CHANGES TO THE APPROVED SECONDARY LABEL LID AND TO IMPLEMENT AN ALTERNATE SECONDARY PRINTING OPERATION ASSOCIATED WITH THE IMPLEMENTATION OF THESE MINOR LABELING CHANGES.
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 |