|
Device | AMPLATZER MUSCULAR VSD OCCLUDER |
Generic Name | Transcatheter septal occluder |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P040040 |
Supplement Number | S023 |
Date Received | 02/19/2013 |
Decision Date | 07/26/2013 |
Product Code |
MLV |
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 APPROVAL FOR AN ALTERNATE SOURCE OF ROUTINE BIOBURDEN AND STERILITY TESTING, AS WELL AS CHANGES TO THE BIOBURDEN TESTING PROTOCOL. |