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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.
 
DeviceSENSAR 1-PIECE LENS MODEL AAB00
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS053
Date Received10/20/2014
Decision Date11/15/2014
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE FROM MACHINED TO A MOLDED IOL EDGE BLOCKER, CHANGE IN CYCLE TIME FOR THE IOL TUMBLING PROCESS, ADDITION OF A COSMETIC INSPECTION FOLLOWINGSTERILIZATION, CHANGE IN TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF IOLS, ANDNEW ULTRA HIGH PERFORMANCE LIQUID CHROMATOGRAPHY EQUIPMENT FOR TESTING RESIDUAL MONOMER LEVELS OF IOL SOFT ACRYLIC MATERIAL.
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