PMA P040042S029
- Device
- THERAPY DUAL ABLATION CATHETER, SAFIRE TX ABLATION CATHETER
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S029
- Product code
- OAD
- Decision date
- 2015-07-09
- 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 CHANGES IN THE CLEANING AND RE-STERILIZATION INSTRUCTIONS IN THE LABELING FOR CONNECTOR CABLES USED IN CARDIAC ABLATION DEVICES.
Current openFDA PMA Record#
- Device
- THERAPY DUAL ABLATION CATHETER, SAFIRE TX ABLATION CATHETER
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S029
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2015-07-09
- Decision code
- APPR
- Date received
- 2014-11-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES IN THE CLEANING AND RE-STERILIZATION INSTRUCTIONS IN THE LABELING FOR CONNECTOR CABLES USED IN CARDIAC ABLATION DEVICES.