|
Device | Amplatzer Muscular VSD Occluder |
Generic Name | Transcatheter septal occluder |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P040040 |
Supplement Number | S045 |
Date Received | 11/22/2021 |
Decision Date | 01/13/2022 |
Product Code |
MLV |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling changes to update the MRI Conditional information in the Instructions for Use (IFU) and Patient Implant Cards (PIC) supplied with the impacted Amplatzer Occluder devices. |