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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 NameMODELS P328UV,P329UV,P351UV,P356UV, & P359UV LENS
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantSTORZ OPHTHALMICS, INC.
PMA NumberP840039
Supplement NumberS034
Date Received01/17/1992
Decision Date03/31/1993
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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