PMA P130026S096

Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Applicant: St Jude Medical
PMA number: P130026
Supplement: S096
Product code: OAE
Decision date: 2025-12-23
Classification: Cardiovascular
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: Approval for consolidating the integrated cabling of the existing TactiCath SE ablation catheters and introducing a non-sterile, reusable cable in place of the current design.

Current openFDA PMA Record#

Device: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Applicant: St Jude Medical
PMA number: P130026
Supplement: S096
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2025-12-23
Decision code: APPR
Date received: 2025-09-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for consolidating the integrated cabling of the existing TactiCath SE ablation catheters and introducing a non-sterile, reusable cable in place of the current design.