PMA P040014S032
- Device
- Therapy Ablation Catheter including Bi-Directional catheter and Therapy 4mm Thermistor Ablation Catheter
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S032
- Product code
- LPB
- Decision date
- 2017-05-19
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Replacement equipment for final inspection.
Current openFDA PMA Record#
- Device
- Therapy Ablation Catheter including Bi-Directional catheter and Therapy 4mm Thermistor Ablation Catheter
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S032
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2017-05-19
- Decision code
- OK30
- Date received
- 2017-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement equipment for final inspection.