THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR
FDA premarket approval P040042/S002 · decided 2006-06-27
Approval details
- PMA number
- P040042
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- Date received
- 2006-05-01
- Decision date
- 2006-06-27
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A SOFTWARE MODIFICATION THAT ALLOWS THE ELIMINATION OF A MINOR DELAY IN GRAPHICAL RECORDING AND DISPLAYING TIME.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IBI INQUIRY CLEARICE INTRACARDIAC ECHOCARDIOGRAPHY ULTRASOUND IMAGING CATHETER (K070011) | Irvine Biomedical,Inc.(Ibi) | 2007-03-20 |