Impella RP System

FDA Premarket Approval P170011 S024

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.

Pre-market Approval Supplement Details

Approval for one-way data-streaming from the automated impella controller through impella connect for external viewing via the internet

DeviceImpella RP System
Generic NameTemporary Non-roller Type Right Heart Support Blood Pump
ApplicantAbiomed, Inc.
Date Received2020-04-10
Decision Date2020-07-10
Product CodePYX 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Abiomed, Inc. 22 Cherry Hill Drive danvers, MA 01923

Supplemental Filings

Supplement NumberDateSupplement Type
P170011Original Filing
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
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)
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

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