|
Device | Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist |
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 | S042 |
Date Received | 06/03/2022 |
Decision Date | 07/01/2022 |
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 Additional supplier to clean and measure the insertion pins. |