THERAPY CATHETER (NON-IRRIGATED)
FDA premarket approval P040014/S022 · decided 2014-04-28
Approval details
- PMA number
- P040014
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAPY CATHETER (NON-IRRIGATED)
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Irvine Biomedical, Inc.
- Date received
- 2014-03-03
- Decision date
- 2014-04-28
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR CHANGES TO THERMAL AND EGM BOARDS, UPGRADE TO THE FIRMWARE AND SOFTWARE, ADDITION OF REMOTE CONTROL FIBER CORD LENGTHS AND UPDATES TO THE INSTRUCTION FOR USE OF THE AMPERE GENERATOR.
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 |
|---|---|---|
| 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 |