|
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 | S016 |
Date Received | 04/24/2020 |
Decision Date | 05/23/2020 |
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 Add a new sterilization cycle at an approved sterilization facility including the implementation of a new final pack configuration and optimized shippers. |