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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 NumberS009
Date Received10/31/2005
Decision Date11/23/2005
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 
Transfer of non-critical "as/manufactured" dimensional inspections of width, symmetry, outer diameter, arc length, and drill hole placement for machined intacs prescription inserts from biotest laboratories to ocular technology inc.
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