|
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 | S003 |
Date Received | 05/20/2002 |
Decision Date | 06/19/2002 |
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 Change to incoming inspection for tyvek/mylar puches used for packaging the implant and delivery system. |