PMA P220013S011

Device: TactiFlex™ Ablation Catheter, Sensor Enabled™
Applicant: ABBOTT MEDICAL
PMA number: P220013
Supplement: S011
Product code: OAE
Decision date: 2025-03-05
Classification: Cardiovascular
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement: to add Midwest Sterilization Corporation (Midwest) as an ethylene oxide (EO) sterilization vendor for the TactiFlex Ablation Catheter at the Midwest Jackson, MO facility.

Current openFDA PMA Record#

Device: TactiFlex™ Ablation Catheter, Sensor Enabled™
Applicant: ABBOTT MEDICAL
PMA number: P220013
Supplement: S011
Product code: OAE
Generic name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date: 2025-03-05
Decision code: APPR
Date received: 2024-03-15
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to add Midwest Sterilization Corporation (Midwest) as an ethylene oxide (EO) sterilization vendor for the TactiFlex Ablation Catheter at the Midwest Jackson, MO facility.