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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.
 
DeviceSTAAR SURGICAL IMPLANTABLE COLLAMER LENSES
Generic NameLens, intraocular, phakic
ApplicantSTAAR Surgical Company
1911 WALKER AVE.
MONROVIA, CA 91016
PMA NumberP030016
Supplement NumberS004
Date Received03/20/2008
Decision Date04/16/2008
Product Code MTA 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE TUMBLING PROCESS FOR ALL LENSES MANUFACTURED AT THE NIDAU, SWITZERLAND MANUFACTURING FACILITY.
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