PMA P990025S016

Device: NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S016
Product code: LPB
Decision date: 2008-11-07
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: APPROVAL FOR TWO ADDITIONAL QUALITY CONTROL INSPECTION STEPS: 1) ADDING A 100% VISUAL INSPECTION OF THE PCB BOARDS TO VERIFY THAT ALL COMPONENTS ARE PRESENT, AND 2) ADDING AN EEPROM READ STEP DURING THE EXISTING CALIBRATION PROCESS TO VERIFY THAT ALL PCB COMPONENTS ARE PRESENT AND FUNCTIONING PROPERLY.

Current openFDA PMA Record#

Device: NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER
Applicant: Biosense Webster, Inc.
PMA number: P990025
Supplement: S016
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2008-11-07
Decision code: APPR
Date received: 2008-10-09
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR TWO ADDITIONAL QUALITY CONTROL INSPECTION STEPS: 1) ADDING A 100% VISUAL INSPECTION OF THE PCB BOARDS TO VERIFY THAT ALL COMPONENTS ARE PRESENT, AND 2) ADDING AN EEPROM READ STEP DURING THE EXISTING CALIBRATION PROCESS TO VERIFY THAT ALL PCB COMPONENTS ARE PRESENT AND FUNCTIONING PROPERLY.