PMA P040014S005
- Device
- IBI THERAPY CARDIAC ABLATION SYSTEM ERS/1500T RF GENERATOR
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S005
- Product code
- LPB
- Decision date
- 2007-07-13
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR A CHANGE FROM LOT RELEASE TO PARAMETRIC RELEASE.
Current openFDA PMA Record#
- Device
- IBI THERAPY CARDIAC ABLATION SYSTEM ERS/1500T RF GENERATOR
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S005
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2007-07-13
- Decision code
- APPR
- Date received
- 2006-12-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE FROM LOT RELEASE TO PARAMETRIC RELEASE.