PMA P960016S092

Device: Safire™ Bi-Directional Ablation Catheter; Safire™ Catheter Extension Cable
Applicant: St Jude Medical
PMA number: P960016
Supplement: S092
Product code: LPB
Decision date: 2025-04-10
Classification: Cardiovascular
Generic name: Cardiac ablation percutaneous catheter
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: Safire™ Bi-Directional Ablation Catheter; Safire™ Catheter Extension Cable
Applicant: St Jude Medical
PMA number: P960016
Supplement: S092
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
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