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 | S019 |
Date Received | 10/30/2019 |
Decision Date | 11/25/2019 |
Product Code |
PYX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Use an additional sterilization chamber at the current sterilization facility for the ethelene oxide sterilization of Impella products. |
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