|
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 | S002 |
Date Received | 06/05/2015 |
Decision Date | 06/17/2015 |
Product Code | |
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. |