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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 NameCRYSTALENS? MODELS AT-50SE AND AT-52SE ACCOMMODATING INTRAOCULAR LENSES (IOLS)
Classification Namelens,intraocular,accommodative
Regulation Number886.3600
ApplicantEYEONICS, INC.
PMA NumberP030002
Supplement NumberS010
Date Received04/06/2007
Decision Date07/26/2007
Product Code
NAA[ Registered Establishments with NAA ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the models at-50se and at-52se accommodating iols used with the staar msi-pf/tf injector and mtc-60c cartridge.
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