|
Trade Name | IMPELLA RP SYSTEM |
Classification Name | right ventricular bypass (assist) device |
Generic Name | right ventricular bypass (assist) device |
Applicant |
ABIOMED, INC. |
22 cherry hill dr. |
danvers, MA 01923 |
|
HDE Number | H140001 |
Supplement Number | S005 |
Date Received | 12/22/2015 |
Decision Date | 01/11/2016 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for design changes to the inlet housing of the impella rp catheter. |