|
Device | AMPLATZER VSD MUSCULAR OCCLUDER |
Generic Name | Transcatheter septal occluder |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P040040 |
Supplement Number | S022 |
Date Received | 02/06/2013 |
Decision Date | 10/29/2014 |
Product Code |
MLV |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CONVERTING THE NITINOL WIRE USED IN THE MANUFACTURE OF THESE DEVICES FROM A BLACK OXIDE SURFACE FINISH TO A CHEMICALLY ETCHED SURFACE FINISH. |