THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR
FDA premarket approval P040042/S004 · decided 2006-09-20
Approval details
- PMA number
- P040042
- Supplement
- S004
- 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
- 2006-08-01
- Decision date
- 2006-09-20
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ADDITION OF AN EXTENDER MODULE TO THE ACCESSORY LIST FOR THE GENERATOR. THE EXTENDER MODULE WILL ALLOW THE USER TO PLACE THE GENERATOR UP TO AN ADDITIONAL TWENTY FEET FROM THE PATIENTS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |