PMA P950005S042

Device: CELSIUS CATHETER, CELSIUS RMT CATHETER, EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION
Applicant: Biosense Webster, Inc.
PMA number: P950005
Supplement: S042
Product code: LPB
Decision date: 2013-07-22
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: APPROVAL FOR THE TRANSFER OF THE GRINDING PROCESS FROM IRWINDALE, CALIFORNIA MANUFACTURING FACILITY TO JUAREZ, MEXICO MANUFACTURING FACILITY.

Current openFDA PMA Record#

Device: CELSIUS CATHETER, CELSIUS RMT CATHETER, EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION
Applicant: Biosense Webster, Inc.
PMA number: P950005
Supplement: S042
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2013-07-22
Decision code: APPR
Date received: 2013-03-21
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE TRANSFER OF THE GRINDING PROCESS FROM IRWINDALE, CALIFORNIA MANUFACTURING FACILITY TO JUAREZ, MEXICO MANUFACTURING FACILITY.