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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
ApplicantOPHTHALMIC INNOVATIONS INTL., INC.
PMA NumberP970034
Supplement NumberS011
Date Received08/13/2008
Decision Date09/12/2008
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the tumbling process.
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