|
Device | TactiCath Quartz Contact Force Ablation Catheter |
Generic Name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Applicant | St. Jude Medical One St. Jude Medical Drive St. Paul, MN 55117 |
PMA Number | P130026 |
Supplement Number | S035 |
Date Received | 07/05/2018 |
Decision Date | 07/31/2018 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for manufacturing modifications to the irrigation lumen subassembly process and includes updates to the polyimide tube cutting fixture and placement of polyimide tube over adhesive covered Inox irrigation tube. |