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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 PRESCRIPTION INSERTS
Classification Nameimplant, corneal, refractive
ApplicantADDITION TECHNOLOGY
PMA NumberP980031
Supplement NumberS006
Date Received05/14/2003
Decision Date11/05/2003
Product Code
LQE[ Registered Establishments with LQE ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site in sunnyvale, california.
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