IBI THERAPY CARDIAC ABLATION SYSTEM
FDA premarket approval P040014/S006 · decided 2007-03-16
Approval details
- PMA number
- P040014
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IBI THERAPY CARDIAC ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Irvine Biomedical, Inc.
- Date received
- 2007-02-12
- Decision date
- 2007-03-16
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LPB
- 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 ABLATION CATHETER AND IBI 1500T9 RT ABLATION GENERATOR. THE THERAPY ABLATION CATHETER IS INDICATED FOR MAPPING AND FOR USE WITH THE IBI 1500T9 RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; THE
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER (K082061) | Irvine Biomedical, Inc. | 2008-08-19 |
| INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER (K060757) | Irvine Biomedical, Inc. | 2006-04-19 |
| INQUIRY AFOCUS II DIAGNOSTIC CATHETER (K053582) | Irvine Biomedical, Inc. | 2006-03-21 |
| INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER (K042775) | Irvine Biomedical, Inc. | 2004-11-04 |
| AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 (K010471) | Irvine Biomedical, Inc. | 2001-06-06 |
| LUMA-CATH STEERABLE EP CATHETERS (K991878) | Irvine Biomedical, Inc. | 1999-12-10 |
| LUMA-CATH FIXED CURVE EP CATHETERS (K991025) | Irvine Biomedical, Inc. | 1999-10-15 |
| ORTHOGONAL EP CATHETERS (K990958) | Irvine Biomedical, Inc. | 1999-06-03 |