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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 LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAAREN SCIENTIFIC
4290 EAST BRICKELL ST, BLDG A
ONTARIO, CA 91761
PMA NumberP970034
Supplement NumberS014
Date Received10/28/2009
Decision Date03/12/2010
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR PARAMETER CHANGES IN THE STERILIZATION CYCLE.
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