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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.
 
DeviceVIEWPOINT CK SYSTEM
Generic NameElectrosurgical, radio frequency, refractive correction
ApplicantRefractec, Inc.
5 Jenner, Suite 150
Irvine, CA 92618
PMA NumberP010018
Supplement NumberS003
Date Received07/10/2003
Decision Date11/06/2003
Product Code MWD 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR UPDATING THE LABELING WITH THE 24 MONTH CLINICAL STUDY RESULTS.
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