PMA P040014S019
- Device
- THERAPY CARDIAC ABLATION SYSTEM
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S019
- Product code
- LPB
- Decision date
- 2012-08-22
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR AN ADDITIONAL VENDOR OF A GENERATOR COMPONENT.
Current openFDA PMA Record#
- Device
- THERAPY CARDIAC ABLATION SYSTEM
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S019
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2012-08-22
- Decision code
- APPR
- Date received
- 2011-11-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ADDITIONAL VENDOR OF A GENERATOR COMPONENT.