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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 NamePOSTERIOR CHAMBER INTRAOCULAR LENSES
Classification Nameintraocular lens
Generic Nameuv-absorbing posterior chamber intraocular lenses
Regulation Number886.3600
ApplicantOPHTHALMIC INNOVATIONS INTL., INC.
PMA NumberP970034
Supplement NumberS008
Date Received03/26/2001
Decision Date12/31/2001
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for model ub55ac posterior chamber intraocular lens.
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