PMA P040042S032
- Device
- THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S032
- Product code
- OAD
- Decision date
- 2015-10-21
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- TO REMOVE A REDUNDANT RUN-IN TEST FOR THE AMPERE SYSTEM FROM THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S032
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2015-10-21
- Decision code
- OK30
- Date received
- 2015-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO REMOVE A REDUNDANT RUN-IN TEST FOR THE AMPERE SYSTEM FROM THE MANUFACTURING PROCESS.