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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 MULTIPIECE SILICONE POSTERIOR CHAMBER ACCOMODATING INTRAOCULAR LENS (IOL)
Classification Namelens,intraocular,accommodative
Regulation Number886.3600
ApplicantEYEONICS, INC.
PMA NumberP030002
Supplement NumberS002
Date Received08/30/2004
Decision Date09/29/2004
Product Code
NAA[ Registered Establishments with NAA ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the device description in the physician labeling.
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