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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINTACS CORNEAL IMPLANTS
Classification Nameimplant, corneal, refractive
ApplicantADDITION TECHNOLOGY
PMA NumberP980031
Supplement NumberS012
Date Received12/13/2012
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 from the firms current facility to its new facility.
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