|
Device | AMPLATZER SEPTAL OCCLUDER & MULTI-FENESTRATED SEPTAL OCCLUDER CRIBRIFORM |
Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P000039 |
Supplement Number | S026 |
Date Received | 02/25/2008 |
Decision Date | 07/15/2008 |
Product Code |
MAE |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ELIMINATION OF A DUPLICATE IN-PROCESS LOAD TEST INSPECTION. |