PMA P040042S011
- Device
- SAFIRE TX CATHETER
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S011
- Product code
- OAD
- Decision date
- 2007-10-19
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- REROUTING OF ONE SET OF THERMOCOUPLE WIRES AND A MODIFICATION TO THE ACTIVATION WIRE.
Current openFDA PMA Record#
- Device
- SAFIRE TX CATHETER
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S011
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2007-10-19
- Decision code
- OK30
- Date received
- 2007-09-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REROUTING OF ONE SET OF THERMOCOUPLE WIRES AND A MODIFICATION TO THE ACTIVATION WIRE.