|
Device | Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, 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 | S115 |
Date Received | 10/30/2023 |
Decision Date | 11/29/2023 |
Product Code |
OZD |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the IFU update of Impella Ventricular Support Systems to provide warning and potential adverse events associated with using Impella Left Ventricular Support catheters with TAVR devices. |