PMA P020025S100
- Device
- Blazer II XP Cardiac Ablation Catheter and Cable
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S100
- Product code
- OAD
- Decision date
- 2017-05-12
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Sterilization of devices within the scope of this bundled submission with the optimized BSC2000-2 cycle in Chamber 3 at the Synergy Health/Steris, Costa Rica facility.
Current openFDA PMA Record#
- Device
- Blazer II XP Cardiac Ablation Catheter and Cable
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S100
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2017-05-12
- Decision code
- OK30
- Date received
- 2017-04-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Sterilization of devices within the scope of this bundled submission with the optimized BSC2000-2 cycle in Chamber 3 at the Synergy Health/Steris, Costa Rica facility.