PMA P150005S030
- Device
- Blazer Open Irrigated Cardiac Ablation System
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S030
- Product code
- OAD
- Decision date
- 2017-11-01
- 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 software control system and the vacuum pump used in Sterilization Chamber 1 at the BSC Coventry Rhode Island facility.
Current openFDA PMA Record#
- Device
- Blazer Open Irrigated Cardiac Ablation System
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S030
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2017-11-01
- Decision code
- OK30
- Date received
- 2017-10-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the software control system and the vacuum pump used in Sterilization Chamber 1 at the BSC Coventry Rhode Island facility.