Impella RP, Impella RP with Smart Assist

FDA Premarket Approval P170011 S041

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, Impella RP with Smart Assist
Generic NameTemporary Non-roller Type Right Heart Support Blood Pump
ApplicantAbiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS041 Date Received05/24/2022 Decision Date06/16/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-24
Decision Date2022-06-16
PMAP170011
SupplementS041
Product CodePYX 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbiomed, Inc.
22 Cherry Hill Drive
danvers, MA 01923 PMA NumberP170011 Supplement NumberS041 Date Received05/24/2022 Decision Date06/16/2022 Product Code PYX  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
implementation Of A Centralized Inert Gas Distribution System At A Manufacturing Facility

Supplemental Filings

Supplement NumberDateSupplement Type
P170011Original Filing
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

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