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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.
 
DevicePREFLEX
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberN17974
Supplement NumberS048
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 MANUFACTURING PROCESS TO INCLUDE ELIMINIATING AIR BLOWING OF EMPTY BOTTLES AND INCLUDING SPECIFICATIONS FOR CONTROL OF PARTICULATE LEVELS FOR BOTTLES RECEIVED FROM VENDORS
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