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, and Impella 5.5 with SmartAssist |
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 | S072 |
Date Received | 03/30/2020 |
Decision Date | 08/04/2020 |
Product Code |
OZD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for: 1) a new design for the Impella 2.5, Impella CP, and Impella CP with SmartAssist pigtail subcomponent; 2) the addition of a second supplier for the new pigtail design; and 3) a change in material and supplier of the encapsulant on the optical sensor used on the Impella CP with SmartAssist and the Impella 5.5 with SmartAssist catheters. |
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