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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameUV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
Generic Nameuv-absorbing posterior chamber intraocular lenses
ApplicantAAREN SCIENTIFIC
PMA NumberP970034
Supplement NumberS014
Date Received10/30/2009
Decision Date03/12/2010
Advisory Committee Neurology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for parameter changes in the sterilization cycle.
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