Impella RP and Impella RP with SmartAssist

FDA Premarket Approval P170011 S036

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

DeviceImpella RP and Impella RP with SmartAssist
Generic NameTemporary Non-roller Type Right Heart Support Blood Pump
ApplicantAbiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS036 Date Received12/17/2021 Decision Date03/16/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2021-12-17
Decision Date2022-03-16
PMAP170011
SupplementS036
Product CodePYX 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbiomed, Inc.
22 Cherry Hill Drive
danvers, MA 01923 PMA NumberP170011 Supplement NumberS036 Date Received12/17/2021 Decision Date03/16/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For An Alternative Luer To Be Used In The Manufacture Of The Purge Sidearm Assembly

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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