|
Device | LIVEWIRE TC CARDIAC ABLATION SYSTEM-CABLE 10X ETO REUSE/RESTERILIZATION, NEW EXTENSION CABLE |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S012 |
Date Received | 07/15/2003 |
Decision Date | 11/21/2003 |
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 THE NEW LIVEWIRE TC CATHETER EXTENSION CABLE-STOCKERT, A NEW CABLE WITH THERMOCOUPLE SENSING ONLY FOR USE WITH THE STOCKERT 70 RADIOFREQUENCY CARDIAC ABLATION GENERATOR. |