|
Trade Name | Amplatzer Post-infarct Muscular VSD Occluder |
Classification Name | transcatheter septal occluder |
Generic Name | transcatheter septal occluder |
Applicant |
Abbott Medical |
177 county road b east |
st. paul, MN 55117 |
|
HDE Number | H070005 |
Supplement Number | S012 |
Date Received | 11/25/2019 |
Decision Date | 01/24/2020 |
Product Code | |
Advisory Committee |
Cardiovascular |
Clinical Trials |
NCT03165526
|
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol for the post-approval study (pas) protocol. |