FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Fluid, Intraocular
PMA: P910071
·
Supplement: S015
·
Decision Aug 28, 2015
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Fluid, Intraocular
- Trade Name
- ADATO SIL-OL 5000 SILICONE OIL
- PMA Number
- P910071
- 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
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- August 28, 2015
- Date Received
- August 7, 2015
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
ADDITION OF A REINFORCING HEAD SEAM TO THE INNER POUCH OF THE DEVICE.
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 |