|
Device | Amplatzer Patent foramen Ovale Occluder |
Generic Name | Transcatheter septal occluder |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P120021 |
Supplement Number | S007 |
Date Received | 02/12/2018 |
Decision Date | 03/12/2018 |
Product Code |
MLV |
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 Implementation of parametric release method at specified cycles and chambers. |