PMA P010068S023
- Device
- NAVISTAR, CELSIUS, QWIKSTAR, EZ STEER BI-DIRECTIONAL, NAVISTAR RMT DUAL SENOR (8MM) DIAGNOSTIC/ABLATION DEFLECTABLE
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S023
- Product code
- OAD
- Decision date
- 2012-02-08
- 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 AN INCREASE IN THE NUMBER OF ALLOWED ETO STERILIZATION CYCLES, AND A MODIFICATION TO THE WORKMANSHIP INSPECTION PERFORMED BY QUALITY CONTROL.
Current openFDA PMA Record#
- Device
- NAVISTAR, CELSIUS, QWIKSTAR, EZ STEER BI-DIRECTIONAL, NAVISTAR RMT DUAL SENOR (8MM) DIAGNOSTIC/ABLATION DEFLECTABLE
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S023
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2012-02-08
- Decision code
- APPR
- Date received
- 2011-03-01
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN INCREASE IN THE NUMBER OF ALLOWED ETO STERILIZATION CYCLES, AND A MODIFICATION TO THE WORKMANSHIP INSPECTION PERFORMED BY QUALITY CONTROL.