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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.
 
DevicePERFLUORON
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantALCON LABORATORIES
6201 SOUTH FREEWAY R3-48
FORT WORTH, TX 76134
PMA NumberP950018
Supplement NumberS015
Date Received01/30/2012
Decision Date03/30/2012
Product Code LWL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MINOR LABELING CHANGES TO THE APPROVED SECONDARY LABEL LID AND TO IMPLEMENT AN ALTERNATE SECONDARY PRINTING OPERATION ASSOCIATED WITH THE IMPLEMENTATION OF THESE MINOR LABELING CHANGES.
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