PMA P020025S122
- Device
- Blazer II XP Cardiac Ablation Catheter and Cable
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S122
- Product code
- OAD
- Decision date
- 2019-11-07
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Reduce the Ethylene Oxide gas concentration and qualify additional process challenge devices used in the BSC2000-2 sterilization cycle.
Current openFDA PMA Record#
- Device
- Blazer II XP Cardiac Ablation Catheter and Cable
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S122
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2019-11-07
- Decision code
- OK30
- Date received
- 2019-10-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduce the Ethylene Oxide gas concentration and qualify additional process challenge devices used in the BSC2000-2 sterilization cycle.