PMA P150005S063
- Device
- Blazer Open-Irrigated Ablation Catheter
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S063
- Product code
- OAD
- Decision date
- 2021-07-14
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Addition of a new vendor for the tip and ring electrode.
Current openFDA PMA Record#
- Device
- Blazer Open-Irrigated Ablation Catheter
- Applicant
- Boston Scientific Corp
- PMA number
- P150005
- Supplement
- S063
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-07-14
- Decision code
- OK30
- Date received
- 2021-06-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new vendor for the tip and ring electrode.