- Device
- IntellaNav ST Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II HTD Temperature Ablation Catheter, a
- Applicant
- Boston Scientific Corp
- PMA number
- P920047
- Supplement
- S124
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-08-05
- Decision code
- APPR
- Date received
- 2020-12-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an adhesive change, minor manufacturing changes, and modification of a product specification.