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TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Abbott Medical
Trade Name
TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C
Generic Name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision Date
5/18/2023
Days to Decision
276 days
Decision Code
APPR
FDA Decision
Approval

TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Abbott Medical
Trade Name
TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™ Quartz, TactiFlex™ Radiofrequency C
Generic Name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision Date
5/18/2023
Days to Decision
276 days
Decision Code
APPR
FDA Decision
Approval