PMA P010068S013
- Device
- NAVISTAR RMT DS DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S013
- Product code
- OAD
- Decision date
- 2008-11-07
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- 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 DS DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S013
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- 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.