PMA P020025S117
- Device
- Blazere II Ablation Catheters, Blazer II XP Ablation Catheters, Blazer Prime Ablation Catheters
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S117
- Product code
- OAD
- Decision date
- 2019-04-16
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Addition of two Thermistor Temperature Accuracy Test Systems for use during the final inspection.
Current openFDA PMA Record#
- Device
- Blazere II Ablation Catheters, Blazer II XP Ablation Catheters, Blazer Prime Ablation Catheters
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S117
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-04-16
- Decision code
- OK30
- Date received
- 2019-03-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of two Thermistor Temperature Accuracy Test Systems for use during the final inspection.