|
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 | S033 |
Date Received | 09/27/2010 |
Decision Date | 01/07/2011 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FOLLOWING: FOR ONLY THE UNIDIRECTIONAL LIVEWIRE TC MODEL - A MODIFICATION OF THE TIP ATTACHMENT DESIGN AND CHANGE OF DISTAL TIP HEAT SHRINK TUBING MATERIAL FROM PTFE TO PTE. FOR BOTH THE UNIDIRECTIONAL AND BIDIRECTIONAL LIVEWIRE TC MODELS - AUTOMATION OF THE EPOXY MIXING AND APPLICATION PROCESS DURING ASSEMBLY OF THE PULL WIRE, REMOVAL OF IN-PROCESS PULL TEST REQUIREMENT, INCREASE IN THE LENGTH TOLERANCE OF THE FLAT WIRE BY 0.1 INCHES AND AUTOMATION OF THE DISPENSING OF BRAZE PASTE. |