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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.
 
DeviceAOSEPT (R) LENS CUP & AODISC NEUTRALIZER
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantCiba Vision Care
11460 Johns Creek Pkwy.
Duluth, GA 30136
PMA NumberP820040
Supplement NumberS032
Date Received09/08/1994
Decision Date10/23/1995
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE CURRENTLY APPROVED AOSEPT LENS CUP AND AODISC NEUTRALIZER TO INLCUDE A CUP MANUFACTURING SITE CHANGE, CUP MATERIAL CHANGE, CUP AND DISC DESIGN CHANGE, AND CORRESPONDING LABELING CHANGES. THE NEW PRIMARY MANUFACTURING SITE IS TENAX CORPORATION, 124 FRANKLIN PARK AVENUE, YOUNGSVILLE, NC 27596. SECONDARY MANUFACTURING SITE IS TENAX CORP, 2450 LAURA DUNCAN ROAD, APEX, NC 27502
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