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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 | S001 |
Date Received | 11/16/2006 |
Decision Date | 03/23/2010 |
Product Code | |
Advisory Committee |
Ophthalmic |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the 0. 21rim, 0. 40mm and 0. 45mm intacs® prescription inserts for the treatment of keratoconus. |