|
Device | IMPELLA CP 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 | S011 |
Date Received | 06/17/2016 |
Decision Date | 11/03/2016 |
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 modifying the inspection criteria for the pump housing component for the Impella CP device. |