|
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 | S008 |
Date Received | 02/03/2017 |
Decision Date | 02/23/2017 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Modifications to the quality inspection method for the purge systems of the impella rp catheter. |