PMA P040042S034
- Device
- THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S034
- Product code
- OAD
- Decision date
- 2016-02-29
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Acceptance of an automated process for Ampere Generator region configuration.
Current openFDA PMA Record#
- Device
- THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S034
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2016-02-29
- Decision code
- OK30
- Date received
- 2016-02-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Acceptance of an automated process for Ampere Generator region configuration.