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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 NameCRYSTLENS MODEL AT-45 ACCOMODATING INTROCULAR LENS
Classification Namelens,intraocular,accommodative
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP030002
Supplement NumberS024
Date Received07/15/2011
Decision Date09/08/2011
Product Code
NAA[ Registered Establishments with NAA ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the labeling to include the addition of 0. 25 diopter increments for the +17 to +27 power range for the crystalens accommodating intraocular lens, model at52ao.
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