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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePERFLUORON OCULAR ENDOTAMPONADE
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantAlcon Laboratories
6201 S. Fwy., R3-48
Fort Worth, TX 76134
PMA NumberP950018
Supplement NumberS016
Date Received11/08/2012
Decision Date07/09/2013
Product Code LWL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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