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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 NumberS005
Date Received08/23/2005
Decision Date09/26/2005
Product Code
NAA[ Registered Establishments with NAA ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the ?recommendations for maximizing patient outcomes? section of the physicians labeling.
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