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 S062

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 add an alternative ultrasonic bonding workstation for a wire bonding process used in the manufacturing of the impella 5. 0 system, impella ld system, and impella rp system

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 Received2019-10-25
Decision Date2019-11-20
PMAP140003
SupplementS062
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

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.