|
Device | TactiCath Contact Force Ablation Catheter, Sensor Enabled |
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 | S051 |
Date Received | 09/12/2019 |
Decision Date | 10/09/2019 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of a warning statement to the instructions for use regarding atrioesophageal fistulas. |