|
Device | Impella CP Ventricular Support System |
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 | S019 |
Date Received | 05/23/2017 |
Decision Date | 06/20/2017 |
Product Code |
OZD |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Add a second supplier for the internal motor coil component of the Impella CP catheters. |