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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 NameSENSAR SOFT ACRYLIC UV LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Classification Nameintraocular lens
Generic Name intraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP980040
Supplement NumberS006
Date Received01/03/2005
Decision Date02/04/2005
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the "indications" statements for all legally marketed iols under the above referenced pmas to reflect adults as opposed to adults older than 60 years of age.
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