|
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 | S021 |
Date Received | 05/06/2022 |
Decision Date | 07/20/2022 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Modifications to the instructions for use to include a new section with the findings of the post-approval study. |