PMA P010068S006
- Device
- NAVISTAR DS BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S006
- Product code
- OAD
- Decision date
- 2006-08-29
- 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 USING A NEW HANDLE, PULLER WIRES AND 1 MM LOCATION SENSOR.
Current openFDA PMA Record#
- Device
- NAVISTAR DS BI-DIRECTIONAL DIAGNOSTIC/ABLATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S006
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2006-08-29
- Decision code
- APPR
- Date received
- 2005-09-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR USING A NEW HANDLE, PULLER WIRES AND 1 MM LOCATION SENSOR.