|
Device | Impella Ventricular Support Systems |
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 | S016 |
Date Received | 02/21/2017 |
Decision Date | 04/17/2017 |
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 an additional supplier for the pressure lumen kink protector for the Impella 2.5 and CP Systems. |