PMA P950005S050

Device: CELSIUS CATHETER, CELSIUS RMT CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P950005
Supplement: S050
Product code: LPB
Decision date: 2014-07-02
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: APPROVAL FOR APPLYING A CHANGE IN STERILIZATION RELEASE METHOD TO THE NEW LINE OF CATHETERS AT THE SANTA TERESA, NEW MEXICO FACILITY.

Current openFDA PMA Record#

Device: CELSIUS CATHETER, CELSIUS RMT CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P950005
Supplement: S050
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2014-07-02
Decision code: APPR
Date received: 2014-04-03
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR APPLYING A CHANGE IN STERILIZATION RELEASE METHOD TO THE NEW LINE OF CATHETERS AT THE SANTA TERESA, NEW MEXICO FACILITY.