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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 PC-58NBM & PC-58NBZ IOLS
Classification Nameintraocular lens
Generic Namemodified j & c loop iol
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP820049
Supplement NumberS064
Date Received06/30/1997
Decision Date10/02/1997
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for alternate sterilization parameters for the 100% ethylene oxide (eto) sterilization process for iols sterilized at steri-tech, inc. , salina, puerto rico.
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