PMA P910071S007

Device: ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S)
Applicant: Bausch & Lomb
PMA number: P910071
Supplement: S007
Product code: LWL
Decision date: 2005-12-16
Generic name: Fluid, intraocular
Approval order 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.

Current openFDA PMA Record#

Device: ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S)
Applicant: Bausch & Lomb
PMA number: P910071
Supplement: S007
Product code: LWL
Generic name: Fluid, intraocular
Decision date: 2005-12-16
Decision code: APPR
Date received: 2005-09-06
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.