Impella RP System

FDA Premarket Approval P170011 S021

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 a labeling change related to the use of the automated impella controller (aic) during air transport.

DeviceImpella RP System
Generic NameTemporary Non-roller Type Right Heart Support Blood Pump
ApplicantAbiomed, Inc.
Date Received2020-01-28
Decision Date2020-04-01
PMAP170011
SupplementS021
Product CodePYX 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Abiomed, Inc. 22 Cherry Hill Drive danvers, MA 01923

Supplemental Filings

Supplement NumberDateSupplement Type
P170011Original 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 IDPMASupp
00813502011029 P170011 000
00813502011869 P170011 030
00813502012811 P170011 039

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