|
Device | TactiCath Quartz Contract 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 | S040 |
Date Received | 02/08/2019 |
Decision Date | 03/14/2019 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of a manufacturing aide for the distal tip adhesive application process of the TactiCath Quartz Contact Force Ablation Catheter. |