ADATO SIL-O1 5000 SILICONE OIL
FDA premarket approval P910071/S014 · decided 2012-08-31
Approval details
- PMA number
- P910071
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADATO SIL-O1 5000 SILICONE OIL
- Generic name
- Fluid, intraocular
- Applicant
- Bausch & Lomb
- Date received
- 2012-08-10
- Decision date
- 2012-08-31
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE LABELING CHANGES TO YOUR DIRECTIONS FOR USE (DFU). THE DFU WAS REVISED TO INCLUDE SAFETY INFORMATION REGARDING THE USE OF CO2 LASERS IN INSTANCES WHERE SILICONE OIL MAY HAVE MIGRATED OUT OF THE EYE AND FORMED LESIONS IN THE CONJUCTIVA OR EYELID.
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