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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCRYSTALENS SE, MODEL AT-45 SE
Classification Namelens,intraocular,accommodative
Generic Namelens,intraocular,accommodative
Regulation Number886.3600
Applicant
Bausch & Lomb, Inc.
50 technology drive
irvine, CA 92618
PMA NumberP030002
Supplement NumberS004
Date Received07/05/2005
Decision Date09/08/2005
Product Code
NAA[ Registered Establishments with NAA ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE PHYSICIAN'S LABELING: CHANGE IN THE MODEL NUMBER AND TRADE NAME; CHANGE IN DIRECTIONS FOR USE TO FACILITATE PROPER INSERTION AND ORIENTATION OF THE LENS; AND, CHANGE IN THE EXISTING RECOMMENDATIONS FOR MAXIMIZING PATIENT OUTCOMES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYSTALENS SE (MODEL AT-45 SE) AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO THE REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA. THE CRYSTALENS SE (MODEL AT-45 SE) PROVIDES APPROXIMATELY ONE DIOPTER OF MONOCULAR ACCOMMODATION WHICH ALLOWS FOR NEAR, INTERMEDIATE, AND DISTANCE VISION WITHOUT SPECTACLES.
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