THERAPY COOL PATH ABLATION CATHETER
FDA premarket approval P060019/S013 · decided 2010-12-03
Approval details
- PMA number
- P060019
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAPY COOL PATH ABLATION CATHETER
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Irvine Biomedical, Inc.
- Date received
- 2010-08-30
- Decision date
- 2010-12-03
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO CHANGE THE MATERIAL OF THE EXTENSION TUBE TO INCREASE THE TORQUE RESISTANCE OF THE EXTENSION TUBE DURING HANDLE MANIPULATION. THE MATERIAL OF THE EXTENSION TUBE WILL BE CHANGED FROM A NON-BRAIDED PELLETHANE TO A PEBAX BRAIDED TUBE (72D). ADDITIONALLY, THE LENGTH OF THE EXTENSION TUBE AND THE INTERNAL FLUID LUMEN TUBE WILL BE DECREASED FROM 11 CM TO 4 CM.
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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 |