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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 COLLAMER INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantSTARR SURGICAL CO.
1911 WALKER AVE.
MONROVIA, CA 91016
PMA NumberP990013
Supplement NumberS008
Date Received02/22/2007
Decision Date03/22/2007
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  
ADDITION OF THE OPTOFORM LATHE TO THE MANUFACTURING FACILITY OF STAAR IN MONROVIA, CALIFORNIA.
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