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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 |
Date Received | 03/03/2004 |
Decision Date | 07/26/2004 |
Product Code | |
Docket Number | 06M-0233 |
Notice Date | 06/09/2006 |
Advisory Committee |
Ophthalmic |
Supplement Type | hde original |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the intacs® prescription inserts for keratoconus. This device is indicated for the reduction or elimination of myopia and astigmatism in patients with keratoconus, who are no longer able to achieve adequate vision with their contact lenses or spectacles, so that their functional vision may be restored and the need for a comeal transplant procedure may potentially be deferred. The specific subset of keratoconic patients proposed to be treated with intacs prescription inserts arethose patients: 1) who have experienced a progressive deterioration in their vision, such that they can no longer achieve adequate functional vision on a daily basis with their contact lenses or spectacles; 2) who are 21 years of age or older; 3) who have clear central comeas; 4) who have a comeal thickness of 450 microns or greater at the proposed incision site; and 5) who have comeal transplantation as the only remaining option to improve their functional vision. |
Approval Order | Approval Order |
Summary | Summary of Safety And Probable Benefit |
Labeling | Labeling
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Supplements: |
S001 S003 S004 S005 |