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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 MODEL AT-45 ACCOMMODATING INTRAOCULAR (IOL)
Classification Namelens,intraocular,accommodative
Regulation Number886.3600
ApplicantEYEONICS, INC.
PMA NumberP030002
Supplement NumberS013
Date Received11/05/2007
Decision Date12/12/2007
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 inclusion of the microstaar msi-pr and msi-tr injectors and mtc-60c cartridge in the physician labeling for the crystalens models at-50se and at-52se.
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