|
Device | 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 | S055 |
Date Received | 06/25/2015 |
Decision Date | 08/31/2015 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF A PROCESS AND DESIGN CHANGE FOR THE SHAFT OF THE LIVEWIRE TCABLATION CATHETER. |