PMA P950005S063

Device: WEBSTER CATHETER; CELSIUS THERMOCOOL CATHETER; CELSIUS CATHETER;; CELSIUS RMT CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P950005
Supplement: S063
Product code: LPB
Decision date: 2017-07-17
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: Approval for transfer of the extrusion process for a subcomponent of the catheters from the Cordis Miami facility to the Webster Juarez manufacturing facility.

Current openFDA PMA Record#

Device: WEBSTER CATHETER; CELSIUS THERMOCOOL CATHETER; CELSIUS CATHETER;; CELSIUS RMT CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P950005
Supplement: S063
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2017-07-17
Decision code: APPR
Date received: 2016-11-28
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for transfer of the extrusion process for a subcomponent of the catheters from the Cordis Miami facility to the Webster Juarez manufacturing facility.