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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 |
|
HDE Number | H040002 |
Supplement Number | S004 |
Date Received | 12/12/2012 |
Decision Date | 06/03/2013 |
Product Code | |
Advisory Committee |
Ophthalmic |
Supplement Type | normal 75 day track |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for transfer of distribution, product release, secondary labeling and packaging, and limited secondary labeling and secondary packaging rework operations fromyour firm’s current facility to its new facility. |