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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.
 
DeviceENUCLENE(R) OPHTHALMIC SOLUTION
Generic NameSolution, cleaning / lubricating, artificial eye
ApplicantAlcon Research, Ltd.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberN13787
Supplement NumberS003
Date Received10/25/1999
Decision Date12/10/1999
Withdrawal Date07/27/2012
Product Code MSI 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the alternate manufacturing facility located at Alcon Laboratories, Inc., ASPEX Manufacturing Facility, 6201 South Freeway, Fort Worth, TX 76134.
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