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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 NameSINGLE-PIECE AND THREE PIECE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lenses
Regulation Number886.3600
ApplicantADVANCED VISION SCIENCE
PMA NumberP830033
Supplement NumberS027
Date Received07/28/1994
Decision Date01/29/1996
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change vendors of the polymethylmethacrylate (pmma) material used to manufacture iols aproved under this pma and its supplements.
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