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 | THERASPHERE |
Classification Name | microspheres radionuclide |
Generic Name | microspheres radionuclide |
Applicant |
Boston Scientific Corporation |
300 boston scientific way |
marlborough, MA 01752 |
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HDE Number | H980006 |
Supplement Number | S027 |
Date Received | 04/14/2014 |
Decision Date | 10/15/2014 |
Product Code | |
Advisory Committee |
Radiology |
Supplement Type | normal 75 day track |
Supplement Reason | request for adn |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval in accordance with 613(b) of the food and drug administration safety and innovation act (fdasia), a determination that the humanitarian use device (hud) meets the conditions of either subclause (i) or (ii) under section 520(m)(6)(a)(i) of the federal food, drug, and cosmetic act (fd&c act), as amended by the fdasia, so that the device may be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device (i. E. , for profit). The adn for this device has been determined to be 1. 8 x 4000 = 7200 vials. |
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