PMA P040042S007
- Device
- THERAPY DUAL 8 CARDIAC ABLATION SYSTEM
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S007
- Product code
- OAD
- Decision date
- 2007-07-13
- 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 A CHANGE FROM LOT RELEASE TO PARAMETRIC RELEASE.
Current openFDA PMA Record#
- Device
- THERAPY DUAL 8 CARDIAC ABLATION SYSTEM
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S007
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2007-07-13
- Decision code
- APPR
- Date received
- 2006-12-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE FROM LOT RELEASE TO PARAMETRIC RELEASE.