|
Trade Name | CARDIOSEAL SEPTAL OCCLUSION SYSTEM |
Classification Name | transcatheter septal occluder |
Generic Name | transcatheter septal occluder |
Applicant |
NITINOL MEDICAL TECHNOLOGIES, INC. |
27 wormwood st. |
boston, MA 02210 |
|
HDE Number | H990011 |
Supplement Number | S001 |
Date Received | 05/22/2000 |
Decision Date | 08/04/2000 |
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 a modified loading system. |