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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 LENS (IOL)
Classification Namelens,intraocular,accommodative
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP030002
Supplement NumberS022
Date Received03/08/2010
Decision Date04/30/2010
Product Code
NAA[ Registered Establishments with NAA ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the physician¿s labeling to include the addition of 0. 25 diopter increments for the crystalens model at50ao lenses in the +17 to +27 dioptric power range and for model at52ao lenses in the +16 to +16. 75 dioptric power range.
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