PMA P020025S109
- Device
- Blazer II XP Cardiac Ablation Catheter and Cable
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S109
- Product code
- OAD
- Decision date
- 2017-12-01
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Update the BSC2000-2 cycle conducted in Chamber 5 at the BSC Coventry, RI facility with new Programmable Logic Controller (PLC) software, a replacement vacuum pump with an additional vacuum pump booster, and a new validation documentation structure used to support the system.
Current openFDA PMA Record#
- Device
- Blazer II XP Cardiac Ablation Catheter and Cable
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S109
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2017-12-01
- Decision code
- OK30
- Date received
- 2017-10-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the BSC2000-2 cycle conducted in Chamber 5 at the BSC Coventry, RI facility with new Programmable Logic Controller (PLC) software, a replacement vacuum pump with an additional vacuum pump booster, and a new validation documentation structure used to support the system.