PMA P040014S013
- Device
- THERAPY CARDIAC ABLATION CATHETER/THERAPY 4MM THERMISTOR/THERAPY BI-DIRECTIONAL CATHETERS
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S013
- Product code
- LPB
- Decision date
- 2010-03-23
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- ADDITION OF A LARGER STERILIZATION CHAMBER.
Current openFDA PMA Record#
- Device
- THERAPY CARDIAC ABLATION CATHETER/THERAPY 4MM THERMISTOR/THERAPY BI-DIRECTIONAL CATHETERS
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S013
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2010-03-23
- Decision code
- OK30
- Date received
- 2010-02-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A LARGER STERILIZATION CHAMBER.