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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 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (AIOL), MODELS AT-45-HD100, HD500, AND HD520
Classification Namelens,intraocular,accommodative
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP030002
Supplement NumberS014
Date Received12/17/2007
Decision Date06/19/2008
Product Code
NAA[ Registered Establishments with NAA ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to market the following models in 0. 5 diopter increments: models at-45-hd100 (10 to 33 diopters), hd500 (17. 0 to 33. 0 diopters), and hd520 (10 to 16. 5 diopters). Additionally, approval to recommend use of the staar msi-pr/tr and msi-pf/tf injectors with mtc-60c cartridge to deliver these lens models.
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