Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device. |
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Trade Name | INTACS PRESCRIPTION INSERTS FOR KERATOCONUS |
Classification Name | implant, corneal, refractive |
Generic Name | implant, corneal, refractive |
Applicant |
ADDITION TECHNOLOGY |
820 oak creek drive |
lombard, IL 60148 |
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HDE Number | H040002 |
Supplement Number | S003 |
Date Received | 11/20/2012 |
Decision Date | 12/19/2012 |
Product Code | |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
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