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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.
 
DeviceARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP960028
Supplement NumberS010
Date Received08/06/2003
Decision Date08/25/2003
Product Code MFK 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate 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 MODIFY THE DIRECTIONS FOR USE TO INCLUDE AN ADDITIONAL PRECAUTION/WARNING STATEMENT REGARDING STORAGE CONDITIONS: "AVOID EXPOSURE TO VOLATILE CHEMICALS."
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