|
Device | AMPLATZER SEPTAL OCCLUDER |
Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P000039 |
Supplement Number | S020 |
Date Received | 11/07/2006 |
Decision Date | 01/30/2007 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE DEVICE PACKAGING AND INCLUSION OF A THREE YEAR SHELF LIFE FOR THE ORIGINAL AMPLATZER DUCT OCCLUDER AND SEPTAL OCCLUDER DELIVERY AND EXCHANGE SYSTEMS. |