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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.
 
DeviceINTACS CORNEAL IMPLANTS
Classification Nameimplant, corneal, refractive
Generic Nameimplant, corneal, refractive
Applicant
ADDITION TECHNOLOGY
820 oak creek drive
lombard, IL 60148
PMA NumberP980031
Supplement NumberS012
Date Received12/12/2012
Decision Date06/03/2013
Product Code
LQE[ Registered Establishments with LQE ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
TRANSFER OF DISTRIBUTION, PRODUCT RELEASE, SECONDARY LABELING AND PACKAGING, AND LIMITED SECONDARY LABELING AND SECONDARY PACKAGING REWORK OPERATIONS FROMTHE FIRMS CURRENT FACILITY TO ITS NEW FACILITY.
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