PMA P040042S009
- Device
- SAFIRE TX CARDIAC ABLATION CATHETER AND INTERFACE CABLES
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S009
- Product code
- OAD
- Decision date
- 2007-08-21
- 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 THE SAFIRE TX CARDIAC ABLATION CATHETER MODEL 1642 AND THE MODELS 1740-SW AND 1779-SE INTERFACE CABLES.
Current openFDA PMA Record#
- Device
- SAFIRE TX CARDIAC ABLATION CATHETER AND INTERFACE CABLES
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S009
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2007-08-21
- Decision code
- APPR
- Date received
- 2007-03-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE SAFIRE TX CARDIAC ABLATION CATHETER MODEL 1642 AND THE MODELS 1740-SW AND 1779-SE INTERFACE CABLES.