Note: 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. |
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Device | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD |
Generic Name | Temporary non-roller type left heart support blood pump |
Applicant | ABIOMED, INC. 22 CHERRY HILL DR. DANVERS, MA 01923 |
PMA Number | P140003 |
Supplement Number | S044 |
Date Received | 12/26/2018 |
Decision Date | 04/17/2019 |
Product Code |
OZD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to the Instructions for Use (IFU) to add the option to use either bivalirudin or argatroban to achieve the recommended level of systemic anticoagulation for Impella patients. |
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