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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 NumberS005
Date Received05/02/2003
Decision Date05/30/2003
Product Code
LQE[ Registered Establishments with LQE ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementing the outsourcing of the inspection, cleaning and packaging operations for intacs inserts to the qualified contract manufacturer, biotest laboratories, inc.
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