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 | IMPELLA RP SYSTEM |
Classification Name | right ventricular bypass (assist) device |
Generic Name | right ventricular bypass (assist) device |
Applicant |
ABIOMED, INC. |
22 cherry hill dr. |
danvers, MA 01923 |
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HDE Number | H140001 |
Supplement Number | S001 |
Date Received | 02/09/2015 |
Decision Date | 03/03/2015 |
Product Code | |
Advisory Committee |
Cardiovascular |
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 administrationsafety and innovation act (fdasia), a determination that your 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 your devicemay 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 4,000. |
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