Impella RP System

FDA Premarket Approval P170011 S033

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 of the revised protocol for the post-approval study (pas) protocol.

DeviceImpella RP System
Generic NameTemporary Non-roller Type Right Heart Support Blood Pump
ApplicantAbiomed, Inc.
Date Received2021-05-03
Decision Date2021-07-12
PMAP170011
SupplementS033
Product CodePYX 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination Product No
Applicant Address Abiomed, Inc. 22 Cherry Hill Drive danvers, MA 01923

Supplemental Filings

Supplement NumberDateSupplement Type
P170011Original Filing
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

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