|
Device | AMPLATZER PFO Occluder |
Generic Name | Transcatheter septal occluder |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P120021 |
Supplement Number | S006 |
Date Received | 01/30/2018 |
Decision Date | 03/08/2018 |
Product Code |
MLV |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the sizing guidelines and the inclusion of the long-term follow-up clinical data from the RESPECT trial in the Instructions for Use. |