PMA P040042S022
- Device
- THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S022
- Product code
- OAD
- Decision date
- 2011-06-06
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- IMPLEMENT AN ADDITIONAL MANUFACTURING REWORK STEP.
Current openFDA PMA Record#
- Device
- THERAPY DUAL 8/THERAPY 8MM THERMISTOR/SAFIRE TX ABLATION CATHETERS
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S022
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2011-06-06
- Decision code
- OK30
- Date received
- 2011-05-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENT AN ADDITIONAL MANUFACTURING REWORK STEP.