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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.
 
DeviceMENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Generic NameLens, contact (other material) - daily
ApplicantMENICON CO. LTD.
269A BALLARDVALE ST.
WILMINGTON, MA 01887
PMA NumberP880098
Supplement NumberS012
Date Received11/19/2002
Decision Date12/10/2002
Withdrawal Date 05/05/2008
Product Codes HQD MWL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ALCON UNIQUE-PH MULTI-PURPOSE SOLUTION AS AN ALTERNATE WET SHIPPING SOLUTION FOR THE MENICON SF-P RIGID GAS PERMEABLE CONTACT LENS, LABELING CHANGES TO REFLECT THE USE OF ALCON UNIQUE-PH AS A PACKAGING SOLUTION AND TO UPDATE THE LABELING IN ACCORDANCE WITH RECENTLY APPROVED MENICON RIGID GAS PERMEABLE CONTACT LENS LABELING.
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