PMA P030031S068

Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS THERMO-COOL ELECTROPHYSIOLOGY CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S068
Product code: LPB
Decision date: 2015-06-02
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: ACCEPTANCE OF A SUPPLIER MANUFACTURING SITE CHANGE FOR VACUUM-FORMED PLASTIC TRAY COMPONENTS.

Current openFDA PMA Record#

Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS THERMO-COOL ELECTROPHYSIOLOGY CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P030031
Supplement: S068
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2015-06-02
Decision code: OK30
Date received: 2015-05-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ACCEPTANCE OF A SUPPLIER MANUFACTURING SITE CHANGE FOR VACUUM-FORMED PLASTIC TRAY COMPONENTS.