|
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 | S041 |
Date Received | 02/01/2013 |
Decision Date | 08/22/2013 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR CHANGES TO 1) UPDATE THE MANUFACTURING PROCEDURE TO ALLOW FOR THE USE OF A MOTORIZED STYLET FEEDER TO PUSH THE STYLET THROUGH THE CATHETER LUMEN FOR ELECTRODE STRINGING; AND 2) ADD AN ADDITIONAL STRINGING STYLET OPTION TO THE MANUFACTURING PROCEDURE. |