|
Device | Impella RP System |
Generic Name | Temporary non-roller type right heart support blood pump |
Regulation Number | 870.4360 |
Applicant | Abiomed, Inc. 22 Cherry Hill Drive Danvers, MA 01923 |
PMA Number | P170011 |
Supplement Number | S014 |
Date Received | 08/26/2019 |
Decision Date | 09/24/2019 |
Product Code |
PYX |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of information on heparin anticoagulation management to the Impella systems instructions for use (IFUs). |