|
Device | LIVEWIRE TC AND SAFIRE BIDIRECTIONAL ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S049 |
Date Received | 08/27/2014 |
Decision Date | 11/06/2014 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MINOR DESIGN CHANGE TO THE SOLDER FOR THE APPROVED LIVEWIRE TC AND SAFIRE BIDIRECTIONAL ABLATION CATHETERS. |