PMA P010068S027
- Device
- NAVISTAR® AND CELSIUS® DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S027
- Product code
- OAD
- Decision date
- 2013-03-07
- 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 OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM.
Current openFDA PMA Record#
- Device
- NAVISTAR® AND CELSIUS® DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S027
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2013-03-07
- Decision code
- APPR
- Date received
- 2012-04-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF MODIFICATIONS TO THE STOCKERT70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION AND COOLFLOW® IRRIGATION PUMP AS AN INTEGRATED SYSTEM.