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Companies starting with “ABIOMED”
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- ABIOMED, INC.
- 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- 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 Postapproval Study Protocol Expedited Review Granted? No
- 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- 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 - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
- 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/components/specifications/material Expedited Review Granted? No
- 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
- 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 Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
- ABIOMED CARDIOVASCULAR, INC.
- ABIOMED EUROPE GMBH
- Abiomed Inc.