PMA P950018S016

Device: PERFLUORON OCULAR ENDOTAMPONADE
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S016
Product code: LWL
Decision date: 2013-07-09
Classification: Fluid, Intraocular
Generic name: Fluid, intraocular
Approval order statement: APPROVAL FOR CHANGES TO THE ADHESIVE RESINS (LIMONENE-BASED RESIN TR7125 HAS REPLACED THE CURRENT LIMONENE-BASED RESIN TR1135, AND ETHYLENE VINYL ACETATE RESIN UL8705 HAS REPLACED THE CURRENT EVA RESIN 205W) USED FOR THE TYVEK LID AND VALIDATION OF AN AIR-OVER-STEAM (AOS) STERILIZATION CYCLE TO ALIGN PRACTICES AMONG PRODUCTS WITHIN THE MANUFACTURING FACILITY.

Current openFDA PMA Record#

Device: PERFLUORON OCULAR ENDOTAMPONADE
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S016
Product code: LWL
Generic name: Fluid, intraocular
Decision date: 2013-07-09
Decision code: APPR
Date received: 2012-11-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THE ADHESIVE RESINS (LIMONENE-BASED RESIN TR7125 HAS REPLACED THE CURRENT LIMONENE-BASED RESIN TR1135, AND ETHYLENE VINYL ACETATE RESIN UL8705 HAS REPLACED THE CURRENT EVA RESIN 205W) USED FOR THE TYVEK LID AND VALIDATION OF AN AIR-OVER-STEAM (AOS) STERILIZATION CYCLE TO ALIGN PRACTICES AMONG PRODUCTS WITHIN THE MANUFACTURING FACILITY.