PMA P040014S008
- Device
- THERAPY CARDIAC ABLATION CATHETERS
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S008
- Product code
- LPB
- Decision date
- 2009-06-17
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES IN THE IBI 1500T9 RF GENERATOR WITH SOFTWARE VERSION 1.42.
Current openFDA PMA Record#
- Device
- THERAPY CARDIAC ABLATION CATHETERS
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S008
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2009-06-17
- Decision code
- APPR
- Date received
- 2008-09-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES IN THE IBI 1500T9 RF GENERATOR WITH SOFTWARE VERSION 1.42.