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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.
 
DeviceINTACS (INTRASTROMAL CORNEAL RING SEGMENTS)
Classification Nameimplant, corneal, refractive
Generic Nameimplant, corneal, refractive
Applicant
ADDITION TECHNOLOGY
820 oak creek drive
lombard, IL 60148
PMA NumberP980031
Supplement NumberS002
Date Received12/23/1999
Decision Date01/12/2000
Product Code
LQE[ Registered Establishments with LQE ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested the implementation of a qualified sampling plan for dimensional inspection of the product attributes: width, arc length, outside diameter, symmetry and hole placement.
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