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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.
 
DeviceEC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL)IOLS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantCarl Zeiss Meditec Production, LLC
1040 S. Vintage Ave., Bldg. A
Ontario, CA 91761
PMA NumberP100016
Supplement NumberS002
Date Received12/18/2014
Decision Date04/13/2015
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED IN ONTARIO, CALIFORNIA.
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