PMA P040014S037
- Device
- Therapy Ablation , Therapy 4mm Thermistor Ablation Catheter
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S037
- Product code
- LPB
- Decision date
- 2019-08-28
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Change to the catheter shaft bonding process.
Current openFDA PMA Record#
- Device
- Therapy Ablation , Therapy 4mm Thermistor Ablation Catheter
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S037
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2019-08-28
- Decision code
- OK30
- Date received
- 2019-07-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the catheter shaft bonding process.