Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• 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 Dr.; Danvers, MA 01923
• PMA Number: P170011
• Date Received: 03/30/2017
• Decision Date: 09/20/2017
• Product Code: PYX
• Docket Number: 17M-5884
• Notice Date: 09/22/2017
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT01777607
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
Approval for the Impella RP® System. This device is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area greater than or equal to 1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S010 S011 S001 S002 S003 S023 S024 S006 S007 S014 S026 ; S020 S012 S013 S043 S044 S045 S040 S041 S042 S034 S035 S049 ; S036 S033 S047 S053 S058 S052 S060 S005 S004 S008 S015 S016 ; S017 S018 S019 S021 S022 S027 S028 S009 S025 S037 S048 S050 ; S032 S046 S029 S030 S031 S038 S039 S056 S059 S055 S061 S062 ; S057 S063