PMA P960016S051

Device: LIVEWIRE TC ABLATION CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER
Applicant: St Jude Medical
PMA number: P960016
Supplement: S051
Product code: LPB
Decision date: 2015-02-02
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: APPROVAL FOR A CHANGE TO THE BUCKLE FORCE PRODUCT REQUIREMENT FOR THELIVEWIRE TC AND SAFIRE BI-DIRECTIONAL ABLATION CATHETERS.

Current openFDA PMA Record#

Device: LIVEWIRE TC ABLATION CATHETER AND SAFIRE BI-DIRECTIONAL ABLATION CATHETER
Applicant: St Jude Medical
PMA number: P960016
Supplement: S051
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2015-02-02
Decision code: APPR
Date received: 2014-12-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE TO THE BUCKLE FORCE PRODUCT REQUIREMENT FOR THELIVEWIRE TC AND SAFIRE BI-DIRECTIONAL ABLATION CATHETERS.