Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD

Temporary Non-roller Type Left Heart Support Blood Pump

FDA Premarket Approval P140003 S063

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

To use an additional sterilization chamber at the current sterilization facility for the ethelene oxide sterilization of impella products

DeviceImpella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD
Classification NameTemporary Non-roller Type Left Heart Support Blood Pump
Generic NameTemporary Non-roller Type Left Heart Support Blood Pump
ApplicantABIOMED, INC.
Date Received2019-10-30
Decision Date2019-11-25
PMAP140003
SupplementS063
Product CodeOZD
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABIOMED, INC. 22 Cherry Hill Dr. danvers, MA 01923

Supplemental Filings

Supplement NumberDateSupplement Type
P140003Original Filing
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

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