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Abiomed, Inc.

190 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD Systems (P140003/S059)Abiomed, Inc.2020-02-18
Automated Impella Controller (P170011/S015)Abiomed, Inc.2020-01-30
Automated Impella Controller (P140003/S057)Abiomed, Inc.2020-01-30
Impella RP System (P170011/S020)Abiomed, Inc.2020-01-24
IMPELLA 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist System, and (P140003/S066)Abiomed, Inc.2020-01-22
Impella 5.5 with SmartAssist (P140003/S064)Abiomed, Inc.2019-11-28
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S063)Abiomed, Inc.2019-11-25
Impella RP System (P170011/S019)Abiomed, Inc.2019-11-25
Impella RP (P170011/S018)Abiomed, Inc.2019-11-20
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S062)Abiomed, Inc.2019-11-20
IMPELLA 2.5 System, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella 5.5 with SmartAssist and Impella LD (P140003/S061)Abiomed, Inc.2019-10-30
Impella RP System (P170011/S017)Abiomed, Inc.2019-10-30
Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.0/LD Systems (P140003/S058)Abiomed, Inc.2019-10-03
Impella RP System (P170011/S016)Abiomed, Inc.2019-10-03
Impella 5.5 with SmartAssist (P140003/S050)Abiomed, Inc.2019-09-24
Impella 2.5, Impella CP, Impella CP with SmatAssist, Impella 5.0/LD Systems (P140003/S056)Abiomed, Inc.2019-09-24
Impella RP System (P170011/S014)Abiomed, Inc.2019-09-24
Impella CP with SmartAssist (P140003/S055)Abiomed, Inc.2019-07-03
Impella RP System (P170011/S013)Abiomed, Inc.2019-06-28
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD Systems (P140003/S053)Abiomed, Inc.2019-06-28
Impella 5.0/LD (P140003/S054)Abiomed, Inc.2019-06-28
Impella RP System (P170011/S012)Abiomed, Inc.2019-06-28
Impella CP with SmartAssist (P140003/S052)Abiomed, Inc.2019-06-02
Impella RP (P170011/S011)Abiomed, Inc.2019-05-21
IMPELLA 5.0 System (P140003/S051)Abiomed, Inc.2019-05-06
Impella 5.0 (P140003/S049)Abiomed, Inc.2019-05-06
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD (P140003/S044)Abiomed, Inc.2019-04-17
Impella RP System (P170011/S009)Abiomed, Inc.2019-04-17
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems (P140003/S047)Abiomed, Inc.2019-04-17
Impella RP (P170011/S010)Abiomed, Inc.2019-04-12
Impella 2.5 (P140003/S048)Abiomed, Inc.2019-03-20
Impella CP with SmartAssist (P140003/S046)Abiomed, Inc.2019-03-03
Impella CP System (P140003/S028)Abiomed, Inc.2019-01-09
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems (P140003/S045)Abiomed, Inc.2019-01-07
Impella CP with SmartAssist (P140003/S043)Abiomed, Inc.2018-11-30
Impella CP with SmartAssist (P140003/S042)Abiomed, Inc.2018-11-30
Impella RP System (P170011/S008)Abiomed, Inc.2018-09-25
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems (P140003/S040)Abiomed, Inc.2018-09-25
Impella CP/Impella CP with SmartAssist (P140003/S039)Abiomed, Inc.2018-09-07
Impella 2.5, Impella CP, Impella 5.0 and Impella LD (P140003/S038)Abiomed, Inc.2018-08-28
Impella CP with SmartAssist; Impella 2.5/5.0 LD; Impella CP; Impella LD (P140003/S037)Abiomed, Inc.2018-08-22
Impella RP (P170011/S007)Abiomed, Inc.2018-08-22
Impella RP (P170011/S006)Abiomed, Inc.2018-08-10
Impella CP/LD, Impella 2.5/5.0 (P140003/S033)Abiomed, Inc.2018-07-10
Impella 5.0 System (P140003/S036)Abiomed, Inc.2018-06-07
Impella 2.5 and Impella CP Ventricular Support Systems (P140003/S035)Abiomed, Inc.2018-05-25
Impella 2.5, Impella CP Ventricular Support Systems (P140003/S034)Abiomed, Inc.2018-05-24
Impella 2.5 and Impella CP Ventricular Support System (P140003/S032)Abiomed, Inc.2018-05-18
Impella CP with SmartAssist (P140003/S030)Abiomed, Inc.2018-05-02
Impella 2.5 System, Impella CP System, Impella CP Optical System, Impella 5.0 System, and Impella LD System (P140003/S029)Abiomed, Inc.2018-04-30
Impella RP System (P170011/S005)Abiomed, Inc.2018-04-30
Impella CP System (P140003/S031)Abiomed, Inc.2018-04-16
Impella CP System (P140003/S026)Abiomed, Inc.2018-03-22
Impella RP System (P170011/S002)Abiomed, Inc.2018-02-16
Impella RP System (P170011/S003)Abiomed, Inc.2018-02-16
Impella 2.5 & Impella CP Systems (P140003/S027)Abiomed, Inc.2018-02-08
Impella Ventricular Support Systems (P140003/S018)Abiomed, Inc.2018-02-07
Impella RP System (P170011/S004)Abiomed, Inc.2018-01-16
Impella RP System (P170011/S001)Abiomed, Inc.2017-12-13
Automated Impella Controller (P140003/S025)Abiomed, Inc.2017-11-27
Impella Ventricular Support System (P140003/S020)Abiomed, Inc.2017-11-01
Impella 2.5 System and Impella Ventricular Support Sustems (P140003/S023)Abiomed, Inc.2017-09-21
Impella RP System (P170011)Abiomed, Inc.2017-09-20
Impella 2.5, Impella CP Systems (P140003/S017)Abiomed, Inc.2017-08-22
Impella Ventricular Support Systems (P140003/S024)Abiomed, Inc.2017-08-21
Impella 2.5 and Impella CP Systems (P140003/S022)Abiomed, Inc.2017-08-01
Impella Ventricular Support Systems (P140003/S021)Abiomed, Inc.2017-07-14
Impella CP Ventricular Support System (P140003/S019)Abiomed, Inc.2017-06-20
Impella Ventricular Support Systems (P140003/S016)Abiomed, Inc.2017-04-17
IMPELLA 2.5 SYSTEM (P140003/S014)Abiomed, Inc.2017-04-14
IMPELLA 2.5 SYSTEM (P140003/S013)Abiomed, Inc.2017-01-31
IMPELLA (P140003/S015)Abiomed, Inc.2017-01-25
IMPELLA CP Systems (P140003/S012)Abiomed, Inc.2016-12-07
IMPELLA VENTRICULAR SUPPORT SYSTEM (P140003/S008)Abiomed, Inc.2016-12-01
IMPELLA CP SYSTEM (P140003/S011)Abiomed, Inc.2016-11-03
Impella Ventricular Support Systems (P140003/S010)Abiomed, Inc.2016-08-09
IMPELLA VENTRICULAR SUPPORT SYSTEMS (P140003/S009)Abiomed, Inc.2016-08-09
IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM (P140003/S005)Abiomed, Inc.2016-04-07
IMPELLA VENTRICULAR SUPPORT SYSTEMS (P140003/S004)Abiomed, Inc.2016-04-07
IMPELLA 2.5 SYSTEM (P140003/S007)Abiomed, Inc.2016-01-25
IMPELLA 2.5 SYSTEM (P140003/S001)Abiomed, Inc.2015-11-13
IMPELLA 2.5 SYSTEM (P140003/S006)Abiomed, Inc.2015-11-03
IMPELLA 2.5 SYSTEM (P140003/S003)Abiomed, Inc.2015-07-08
IMPELLA 2.5 SYSTEM (P140003/S002)Abiomed, Inc.2015-06-17
IMPELLA 2.5 System (P140003)Abiomed, Inc.2015-03-23
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