Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Impella RP System |
Generic Name | temporary non-roller type right heart support blood pump |
Regulation Number | 870.4360 |
Applicant | Abiomed, Inc. 22 cherry hill drive danvers, MA 01923 |
PMA Number | P170011 |
Supplement Number | S008 |
Date Received | 09/06/2018 |
Decision Date | 09/25/2018 |
Product Code |
PYX |
Advisory Committee |
Cardiovascular |
Supplement Type | real-time process |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a design change to the optical version of the Automated Impella Controller, adding a cover over the pump plug receptacle. |
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