PMA P960016S001

Device: LIVEWIRE TC CARDIAC ABLATION SYSTEM-ADDITION OF LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY
Applicant: St Jude Medical
PMA number: P960016
Supplement: S001
Product code: LPB
Decision date: 1999-06-18
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: Approval for four curve versions of the TC(TM) catheter line with increased lateral stability, known as the XLS(TM) series.

Current openFDA PMA Record#

Device: LIVEWIRE TC CARDIAC ABLATION SYSTEM-ADDITION OF LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY
Applicant: St Jude Medical
PMA number: P960016
Supplement: S001
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 1999-06-18
Decision code: APPR
Date received: 1999-05-06
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for four curve versions of the TC(TM) catheter line with increased lateral stability, known as the XLS(TM) series.