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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 SOFT ACRYLIC INTRAOCULAR LENSES
ApplicantJohnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine, CA 92618
PMA NumberP980040
Supplement NumberS061
Date Received04/01/2015
Decision Date05/01/2015
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  
IMPLEMENTATION OF A NEW METHOD FOR MEASUREMENT OF THE OPTICAL PROPERTIES(DIOPTER AND IMAGE QUALITY) OF THE 3-PIECE ACRYLIC AND SILICONE IOLS PRODUCED AT AMO¿S PUERTO RICO FACILITY.
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