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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMODELS PC-58NBM & PC-58NBZ IOLS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAdvanced Medical Optics, Inc.
1700 E. St. Andrew Pl.
Santa Ana, CA 92705
PMA NumberP820049
Supplement NumberS060
Date Received12/30/1994
Decision Date10/18/1995
Withdrawal Date07/25/2006
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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