|
Trade Name | AMPLATZER P.I. 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 | S008 |
Date Received | 02/15/2019 |
Decision Date | 03/05/2019 |
Product Code | |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate sterilization site located at sterigenics, 5725 harold gatty drive, salt lake city, utah. |