|
Device | AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM |
Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P020024 |
Supplement Number | S006 |
Date Received | 10/13/2005 |
Decision Date | 02/06/2006 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE END SCREW DESIGN. |
Post-Approval Study | Show Report Schedule and Study Progress |