|
Device | Impella 2.5, CP, and CP 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 | S065 |
Date Received | 12/16/2019 |
Decision Date | 06/26/2020 |
Product Code |
OZD |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding Dexter Magnetic Technologies as a supplier for the motor magnet component for the Impella 2.5, Impella CP, and Impella CP with SmartAssist. |