|
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 | S077 |
Date Received | 12/03/2021 |
Decision Date | 08/17/2022 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for protocol (ABT-CIP-10436 Version A) for the post-approval study (PAS) protocol. |