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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
ApplicantALLERGAN MEDICAL OPTICS
PMA NumberP820049
Supplement NumberS060
Date Received12/30/1994
Decision Date10/18/1995
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 pc-58nbm and pc-58nbz as low-diopter, tier a modifications of a previously approval allergan medical optics lens. These lenses will be offered in powers from -10. 0 to +5. 5 diopters.
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