PMA P950005S046

Device: NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, CELSIUS RMT THERMOCOOL
Applicant: Biosense Webster, Inc.
PMA number: P950005
Supplement: S046
Product code: LPB
Decision date: 2013-10-09
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.

Current openFDA PMA Record#

Device: NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ STEER THERMOCOOL, CELSIUS RMT THERMOCOOL
Applicant: Biosense Webster, Inc.
PMA number: P950005
Supplement: S046
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2013-10-09
Decision code: OK30
Date received: 2013-09-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS.