THERAPY DUAL 8 ABLATION CATHETER & IBI-1500T6 CARDIAC ABLATION GENERATOR
FDA premarket approval P040042/S008 · decided 2007-03-16
Approval details
- PMA number
- P040042
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAPY DUAL 8 ABLATION CATHETER & IBI-1500T6 CARDIAC ABLATION GENERATOR
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- Date received
- 2007-02-12
- Decision date
- 2007-03-16
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A NEW RF GENERATOR, WHICH INCLUDES SOFTWARE AND HARDWARE MODIFICATIONS TO THE PREVIOUSLY APPROVED RF GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERAPY DUAL 8 ABLATION CATHETER AND IBI 1500T9 RF ABLATION GENERATOR. THE THERAPY DUAL 8 ABLATION CATHETER IS INTENDED FOR USE WITH THE IBI 1500T9 RADIOFREQUENCY (RF) ABLATION GENERATOR AT A MAXIMUM OF 100 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPP
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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 |