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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 (KERATOPLAST TIP COMPONENT)
Generic NameElectrosurgical, radio frequency, refractive correction
ApplicantRefractec, Inc.
5 Jenner, Suite 150
Irvine, CA 92618
PMA NumberP010018
Supplement NumberS001
Date Received10/21/2002
Decision Date10/28/2002
Product Code MWD 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ALTERNATIVE/ EQUIVALENT UV CURABLE ADHESIVE TO BE USED IN THE BONDING PROCESS DURING MANUFACTURE OF THE KERATOPLAST TIP.
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