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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.
 
DeviceADAPETTES LUBRICATING AND REWETTING SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberN17945
Supplement NumberS029
Date Received08/25/1995
Decision Date01/04/1996
Withdrawal Date12/22/2003
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 TO USE 100% ETHYLENE OXIDE AS AN ALTERNATE STERILIZATION METHOD OF PRIMARY PACKAGING COMPONENTS - THE ALTERNATE STERILIZATION METHOD WILL BE PERFORMED AS ISOMEDIX, 2072 SOUTHPORT RD., SPARTANBURG, SC
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