PMA P040014S003
- Device
- THERAPY ABLATION CATHETER AND IBI 1500T CARDIAC ABLATION GENERATOR
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S003
- Product code
- LPB
- Decision date
- 2006-11-13
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR BI-DIRECTIONAL FUNCTIONALITY DESIGN MODIFICATIONS TO THE THERAPY ABLATION CATHETER.
Current openFDA PMA Record#
- Device
- THERAPY ABLATION CATHETER AND IBI 1500T CARDIAC ABLATION GENERATOR
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S003
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2006-11-13
- Decision code
- APPR
- Date received
- 2006-06-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR BI-DIRECTIONAL FUNCTIONALITY DESIGN MODIFICATIONS TO THE THERAPY ABLATION CATHETER.