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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.
 
DeviceBIOCURVE SOFT CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantWavetouch Technologies, LLC
15970 Bernardo Center Dr.
San Diego, CA 92127
PMA NumberP860040
Supplement NumberS016
Date Received05/05/2004
Decision Date05/28/2004
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO RELOCATE SOME MANUFACTURING PROCESSES TO THE SITE LOCATED AT AMERICAN BIOCURVE, INC., SAN DIEGO, CALIFORNIA.
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