ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S)
FDA premarket approval P910071/S007 · decided 2005-12-16
Approval details
- PMA number
- P910071
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S)
- Generic name
- Fluid, intraocular
- Applicant
- Bausch & Lomb
- Date received
- 2005-09-06
- Decision date
- 2005-12-16
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR 1) CHANGE OF THE TIP CAP OF THE 10 ML HYPAC SCF SYRINGE FROM CONTAINING DRY NATURAL RUBBER MATERIAL TO LATEX-FREE MATERIAL AND 2) REVISION OF THE LABELING TO REMOVE THE "DRY NATURAL RUBBER" STATEMENT.
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