| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1220648 | 1220648 | ABIOMED, INC. | 1 | N | 2026-01-01 | 22 Cherry Hill Dr DANVERS MA US 01923 |
| 3007904765 | 3007904765 | ABIOMED EUROPE GMBH | 1 | N | 2026-01-01 | Neuenhofer Weg 3 Aachen North Rhine-Westphalia DE 52074 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 1514 | 1655575937 | P900023 | ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM | DSQ | 1992-11-20 |
| 1514 | 1597260964 | P170011 | Impella RP System | PYX | 2017-09-20 |
| 110030 | 1718042238 | P170011 | Impella RP System | PYX | 2017-09-20 |
| 110030 | 1232118858 | P140003 | IMPELLA 2.5 System | OZD | 2015-03-23 |
| 1514 | 1655437629 | P140003 | IMPELLA 2.5 System | OZD | 2015-03-23 |
| 1514 | 1132770485 | K223872 | Low Profile Companion Sheath | DYB | 2023-01-19 |
| 1514 | 1351705537 | K223161 | OXY-1 System | DTZ | 2023-02-23 |
| 1514 | 1630841220 | K222113 | Abiomed 14Fr Low Profile Introducer Set | DYB | 2022-10-13 |
| 1514 | 1966069776 | K201116 | Abiomed 23 Fr Sheath | DYB | 2020-06-15 |
| 1514 | 1553661943 | K192769 | Impella CP Introducer | DYB | 2019-11-18 |
| 110030 | 1934031716 | K112892 | IMPELLA 2.5 PLUS CATHETER | PBL | 2012-09-06 |
| 1514 | 1283807568 | K110845 | IMPELLA CONTROLLER WITH FLOW CONTROL | KFM | 2011-04-27 |
| 1514 | 1623168113 | K070225 | SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE | DSP | 2007-12-13 |
| 1514 | 1180358046 | H140001 | |||
| 1514 | 1162413697 | H040006 | |||
| 1514 | 1408342763 | ||||
| 1514 | 1279946487 | ||||
| 1514 | 1736701679 | ||||
| 1514 | 1781813537 |
ABIOMED, 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 -...
Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS047 Date Received11/03/2022 Decision Date12/05/2022 Product Code PYX Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason ...
Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS046 Date Received09/15/2022 Decision Date10/11/2022 Product Code PYX Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS105 Date Received08/16/2022 Decision Date09/06/2022 Product Code OZD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manu...
ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS103 Date Received08/05/2022 Decision Date08/31/2022 Product Code OZD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manu...
Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS045 Date Received08/05/2022 Decision Date08/31/2022 Product Code PYX Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS102 Date Received07/20/2022 Decision Date08/18/2022 Product Code OZD Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Po...
ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS101 Date Received06/03/2022 Decision Date07/01/2022 Product Code OZD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manu...
Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS042 Date Received06/03/2022 Decision Date07/01/2022 Product Code PYX Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS100 Date Received05/24/2022 Decision Date06/16/2022 Product Code OZD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manu...
Abiomed, 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 - Ma...
Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS038 Date Received03/24/2022 Decision Date04/12/2022 Product Code PYX Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS097 Date Received03/24/2022 Decision Date04/12/2022 Product Code OZD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manu...
Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS036 Date Received12/17/2021 Decision Date03/16/2022 Product Code PYX Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/c...
Abiomed, Inc.22 Cherry Hill Drivedanvers, MA 01923 PMA NumberP170011 Supplement NumberS037 Date Received02/09/2022 Decision Date03/08/2022 Product Code PYX Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Ma...
ABIOMED, INC.22 Cherry Hill Dr.danvers, MA 01923 PMA NumberP140003 Supplement NumberS095 Date Received02/09/2022 Decision Date03/08/2022 Product Code OZD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manu...
Abiomed, Inc.
ABIOMED, INC.
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