Impella RP System

Temporary Non-roller Type Right Heart Support Blood Pump

FDA Premarket Approval P170011

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.

Pre-market Approval Supplement Details

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.

• Device: Impella RP System
• Classification Name: Temporary Non-roller Type Right Heart Support Blood Pump
• Generic Name: Temporary Non-roller Type Right Heart Support Blood Pump
• Applicant: Abiomed, Inc.
• Date Received: 2017-03-30
• Decision Date: 2017-09-20
• Notice Date: 2017-09-22
• PMA: P170011
• Supplement: S
• Product Code: PYX
• Docket Number: 17M-5884
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: Abiomed, Inc. 22 Cherry Hill Drive danvers, MA 01923
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P170011		Original Filing
S047	2022-11-03	Normal 180 Day Track No User Fee
S046	2022-09-15	30-day Notice
S045	2022-08-05	30-day Notice
S044
S043
S042	2022-06-03	30-day Notice
S041	2022-05-24	30-day Notice
S040
S039
S038	2022-03-24	30-day Notice
S037	2022-02-09	30-day Notice
S036	2021-12-17	Real-time Process
S035
S034	2021-07-08	Normal 180 Day Track
S033	2021-05-03	Normal 180 Day Track No User Fee
S032	2021-03-31	Normal 180 Day Track
S031	2020-12-31	Normal 180 Day Track
S030	2020-12-30	Normal 180 Day Track
S029	2020-12-15	Normal 180 Day Track No User Fee
S028	2020-10-16	30-day Notice
S027
S026
S025	2020-06-15	Normal 180 Day Track No User Fee
S024	2020-04-10	Real-time Process
S023	2020-03-23	30-day Notice
S022	2020-03-09	30-day Notice
S021	2020-01-28	Real-time Process
S020	2019-12-26	30-day Notice
S019	2019-10-30	30-day Notice
S018	2019-10-25	30-day Notice
S017	2019-09-30	30-day Notice
S016	2019-09-03	30-day Notice
S015
S014	2019-08-26	Special (immediate Track)
S013	2019-05-31	30-day Notice
S012	2019-05-31	30-day Notice
S011	2019-03-15	Normal 180 Day Track No User Fee
S010	2019-03-15	Special (immediate Track)
S009
S008	2018-09-06	Real-time Process
S007	2018-07-31	30-day Notice
S006	2018-07-25	30-day Notice
S005	2018-02-27	Real-time Process
S004	2018-01-09	30-day Notice
S003	2017-12-18	Normal 180 Day Track No User Fee
S002	2017-12-18	Normal 180 Day Track No User Fee
S001	2017-12-05	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
00813502011029	P170011	000
00813502011869	P170011	030
00813502012811	P170011	039