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Device | LIVEWIRE TC ABLATION CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S066 |
Date Received | 06/01/2016 |
Decision Date | 06/29/2016 |
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 Change to the current Livewire TC and Safire Bi-Directional in-process tensile test frequency for catheter ring brazing and catheter tip brazing. |