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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.
 
DeviceSTARR COLLAMER (TM) UV ABSORBING PC IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantSTARR SURGICAL CO.
1911 WALKER AVE.
MONROVIA, CA 91016
PMA NumberP990013
Supplement NumberS003
Date Received07/06/2001
Decision Date07/20/2001
Product Code HQL 
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 OF MANUFACTURING METHOD FOR STAAR COLLAMER(TM) INTRAOCULAR LENSES THAT INVOLVES THE ADDITION OF A SECONDARY CHROMOPHORE PURIFICATION PROCESS.
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