FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Fluid, Intraocular
PMA: P950018
·
Supplement: S009
·
Decision Mar 20, 2003
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Fluid, Intraocular
- Trade Name
- PERFLUORON
- PMA Number
- P950018
- Supplement Number
- S009
- 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 20, 2003
- Date Received
- February 14, 2003
- Supplement Type
- Real-Time Process
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A NEW STABILITY PROTOCOL THAT WILL EXTEND THE EXPIRATION DATING FOR PERFLUORON FROM 2 YEARS TO UP TO 4 YEARS FOR THE CURRENTLY APPROVED PRODUCT CONFIGURATION, WITH STABILITY TESTING DATA REPORTED VIA ANNUAL REPORTS IN THE FUTURE.
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 |