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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.
 
DeviceACRYSOF SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) WITH THE ACRYSERT DELIVERY SYSTEM
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy. Dr.
Fort Worth, TX 76134
PMA NumberP930014
Supplement NumberS011
Date Received07/25/2003
Decision Date08/29/2003
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ACRYSOF SINGLE-PIECE POSTERIOR CHANGER INTRAOCULAR LENS (IOL) WITH THE ACRYSERT DELIVERY SYSTEM (MODEL SA60AS), AND FOR A SHELF LIFE EXTENSION PROTOCOL.
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