|
Device | LIVEWIRE TC CARDIAC ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | St. Jude Medical 14900 MINNETONKA IND RD MINNETONKA, MN 55345 |
PMA Number | P960016 |
Supplement Number | S043 |
Date Received | 09/19/2013 |
Decision Date | 03/12/2014 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO SEMI-AUTOMATE THE PROCESS TO DECORE THE MANDREL FROM THE CATHETER SHAFT SUBASSEMBLY. |