PMA P040042S020
- Device
- THERAPY DUAL 8 ABLATION CATHETER
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S020
- Product code
- OAD
- Decision date
- 2011-01-11
- 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 DESIGN MODIFICATION TO THE TIP ELECTRODE STEM OUTER DIAMETER (OD) SO THAT THE GAP BETWEEN THE TIP ELECTRODE OD AND TUBE INSIDE DIAMETER (ID) IS REDUCED TO -0.0015¿ TO +0.0015¿ FROM -0.003¿ TO +0.003¿ FOR CONSISTENT GAP INTERFERENCE.
Current openFDA PMA Record#
- Device
- THERAPY DUAL 8 ABLATION CATHETER
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S020
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2011-01-11
- Decision code
- APPR
- Date received
- 2010-11-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A DESIGN MODIFICATION TO THE TIP ELECTRODE STEM OUTER DIAMETER (OD) SO THAT THE GAP BETWEEN THE TIP ELECTRODE OD AND TUBE INSIDE DIAMETER (ID) IS REDUCED TO -0.0015¿ TO +0.0015¿ FROM -0.003¿ TO +0.003¿ FOR CONSISTENT GAP INTERFERENCE.