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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.
 
DeviceUV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAAREN SCIENTIFIC
4290 EAST BRICKELL ST, BLDG A
ONTARIO, CA 91761
PMA NumberP970034
Supplement NumberS010
Date Received12/20/2007
Decision Date04/17/2008
Withdrawal Date 08/20/2014
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN LENS POLISH.
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