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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
Classification Namelens,intraocular,accommodative
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP030002
Supplement NumberS020
Date Received06/02/2009
Decision Date08/05/2011
Product Code
NAA[ Registered Establishments with NAA ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to market crystalens® model at-45 accommodating intraocular lens (iol) with a benzotriazole ultra-violet (uv) absorber chromophore (uvam). To be designated as models at1uv, at2uv, hd1uv, hd2uv, ao1uv and ao2uv.
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