|
Device | Impella 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 | S052 |
Date Received | 05/28/2019 |
Decision Date | 06/02/2019 |
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 two alternative suppliers for a pump housing sub-component used in the Impella CP with SmartAssist System. |