|
Device | IMPELLA 2.5 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 | S002 |
Date Received | 06/05/2015 |
Decision Date | 06/17/2015 |
Product Code |
OZD |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE IMPLEMENTATION OF ADDITIONAL QUALITY CONTROL MEASUREMENTS FOR FLUID TIGHTNESS OF THE IMPELLA PURGE CASSETTE. |