Impella2.5, ImpellaCP, Impella CP with SmartAssist

FDA Premarket Approval P140003 S106

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

DeviceImpella2.5, ImpellaCP, Impella CP with SmartAssist
Generic NameTemporary Non-roller Type Left Heart Support Blood Pump
ApplicantABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS106 Date Received10/14/2022 Decision Date01/06/2023 Product Code OZD  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-10-14
Decision Date2023-01-06
PMAP140003
SupplementS106
Product CodeOZD 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressABIOMED, INC.
22 Cherry Hill Dr.
danvers, MA 01923 PMA NumberP140003 Supplement NumberS106 Date Received10/14/2022 Decision Date01/06/2023 Product Code OZD  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For Various Labeling Updates Regarding Arterial Access And Timing Of Impella Use In The Setting Of Acute Myocardial Infarction Complicated By Cardiogenic Shock.

Supplemental Filings

Supplement NumberDateSupplement Type
P140003Original Filing
S106 2022-10-14 Real-time Process
S105 2022-08-16 30-day Notice
S104
S103 2022-08-05 30-day Notice
S102 2022-07-20 Normal 180 Day Track No User Fee
S101 2022-06-03 30-day Notice
S100 2022-05-24 30-day Notice
S099
S098
S097 2022-03-24 30-day Notice
S096
S095 2022-02-09 30-day Notice
S094
S093
S092
S091
S090
S089 2021-09-15 Real-time Process
S088
S087 2021-07-26 30-day Notice
S086
S085
S084
S083 2021-05-03 Normal 180 Day Track No User Fee
S082 2021-05-03 Normal 180 Day Track No User Fee
S081 2021-05-03 Normal 180 Day Track No User Fee
S080 2021-03-31 Normal 180 Day Track
S079 2021-01-19 30-day Notice
S078
S077 2020-10-16 30-day Notice
S076
S075 2020-08-10 30-day Notice
S074
S073 2020-04-10 Real-time Process
S072
S071 2020-03-23 30-day Notice
S070 2020-02-13 Real-time Process
S069 2020-02-10 30-day Notice
S068
S067
S066 2019-12-23 Special (immediate Track)
S065
S064 2019-11-20 30-day Notice
S063 2019-10-30 30-day Notice
S062 2019-10-25 30-day Notice
S061 2019-09-30 30-day Notice
S060
S059
S058 2019-09-03 30-day Notice
S057
S056 2019-08-26 Special (immediate Track)
S055 2019-06-03 30-day Notice
S054 2019-05-31 30-day Notice
S053 2019-05-31 30-day Notice
S052 2019-05-28 30-day Notice
S051 2019-04-08 30-day Notice
S050
S049 2019-02-27 Real-time Process
S048 2019-02-21 30-day Notice
S047
S046 2019-01-29 30-day Notice
S045 2019-01-03 30-day Notice
S044
S043 2018-11-21 30-day Notice
S042 2018-11-20 30-day Notice
S041
S040 2018-09-06 Real-time Process
S039 2018-08-10 30-day Notice
S038 2018-07-31 30-day Notice
S037 2018-07-31 30-day Notice
S036 2018-05-15 30-day Notice
S035 2018-05-14 30-day Notice
S034 2018-05-10 30-day Notice
S033 2018-05-07 Real-time Process
S032 2018-04-20 30-day Notice
S031 2018-04-05 30-day Notice
S030 2018-03-30 Normal 180 Day Track No User Fee
S029 2018-02-27 Real-time Process
S028 2018-02-13 Normal 180 Day Track
S027 2017-09-29 Normal 180 Day Track
S026 2017-09-05 Normal 180 Day Track
S025 2017-08-29 Real-time Process
S024 2017-07-26 30-day Notice
S023 2017-07-25 Real-time Process
S022 2017-06-30 30-day Notice
S021 2017-06-16 Special (immediate Track)
S020 2017-06-06 135 Review Track For 30-day Notice
S019 2017-05-23 30-day Notice
S018 2017-04-03 Panel Track
S017 2017-03-30 Normal 180 Day Track No User Fee
S016 2017-02-21 135 Review Track For 30-day Notice
S015 2016-12-29 30-day Notice
S014 2016-11-28 Real-time Process
S013 2016-11-14 Real-time Process
S012 2016-06-29 135 Review Track For 30-day Notice
S011 2016-06-17 135 Review Track For 30-day Notice
S010 2016-06-10 Normal 180 Day Track No User Fee
S009 2016-06-10 Normal 180 Day Track No User Fee
S008 2016-06-07 Normal 180 Day Track
S007 2016-01-19 30-day Notice
S006 2015-09-15 Real-time Process
S005 2015-08-13 Panel Track
S004 2015-08-12 Panel Track
S003 2015-06-24 30-day Notice
S002 2015-06-05 Special (immediate Track)
S001 2015-05-22 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00813502011371 P140003 026
00813502011531 P140003 050

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