|
Device | Safire Bi-Directional Ablation Catheters, Livewire TC Ablation Catheter |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S070 |
Date Received | 10/19/2017 |
Decision Date | 10/24/2017 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Installation of additional data loggers for use with the Vaisala Environmental Monitoring System (EMS). |