|
Device | AMPLATZER DUCT OCCLUDER |
Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P020024 |
Supplement Number | S039 |
Date Received | 02/19/2013 |
Decision Date | 07/26/2013 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ALTERNATE SOURCE OF ROUTINE BIOBURDEN AND STERILITY TESTING, AS WELL AS CHANGES TO THE BIOBURDEN TESTING PROTOCOL. |
Post-Approval Study | Show Report Schedule and Study Progress |