PMA P220013S017

Device: TactiFlex™ Ablation Catheter, Sensor Enabled™
Applicant: ABBOTT MEDICAL
PMA number: P220013
Supplement: S017
Product code: OAE
Decision date: 2025-04-10
Classification: Cardiovascular
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: an expansion of sterilization capabilities, including validation of the maximum load configuration, an addition of preconditioning room, and parametric release for Cycle 219 at Centerpiece in Tijuana, Mexico

Current openFDA PMA Record#

Device: TactiFlex™ Ablation Catheter, Sensor Enabled™
Applicant: ABBOTT MEDICAL
PMA number: P220013
Supplement: S017
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2025-04-10
Decision code: OK30
Date received: 2025-03-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an expansion of sterilization capabilities, including validation of the maximum load configuration, an addition of preconditioning room, and parametric release for Cycle 219 at Centerpiece in Tijuana, Mexico