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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.
 
DeviceOPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAlcon Laboratories
R
Van Nuys, CA 30348
PMA NumberP830034
Supplement NumberS028
Date Received08/16/1995
Decision Date09/08/1995
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES IN THE MANUFACTURING PROCESS TO ELIMINATE AIR BLOWING OF EMPTY BOTTLES AND INCLUDING SPECIFICATIONS FOR CONTROL OF PARTICULATE LEVELS FOR BOTTLES RECEIVED FROM VENDORS
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