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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.
 
DeviceACRYSOR SINGLE PIECE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL SA60AT ECTEDED DIOPTER RANGE
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy. Dr.
Fort Worth, TX 76134
PMA NumberP930014
Supplement NumberS010
Date Received09/11/2002
Decision Date10/07/2002
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO EXTEND THE MODEL SA60AT POWER RANGE FROM +6.0D THROUGH +34.0D TO +6.0 THROUGH +40.0D.
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