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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 NameIOL MODELS MZ60PD AND MZ60MD
Classification Nameintraocular lens
Generic Namepost. iols
Regulation Number886.3600
ApplicantALCON LABORATORIES
PMA NumberP840060
Supplement NumberS027
Date Received12/09/1996
Decision Date06/06/1997
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
Approval Order Statement 
Approval for models mz60pd and mz60md posterior chamber iols.
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