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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
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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