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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMODEL 405 SPANFLEX TM IOL
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP880085
Date Received11/15/1988
Decision Date06/27/1991
Withdrawal Date 08/23/2000
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 91M-0247
Notice Date 08/02/1991
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S003 
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