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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 (INTRASTROMAL CORNEAL RING SEGMENTS)
Classification Nameimplant, corneal, refractive
ApplicantKERAVISION, INC.
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: manufacturing
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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