Blazer II XP Temperature Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, IntellaTip MiFi XP Temperatur
FDA premarket approval P020025/S129 · decided 2021-08-05
Approval details
- PMA number
- P020025
- Supplement
- S129
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Blazer II XP Temperature Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, IntellaTip MiFi XP Temperatur
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2020-12-18
- Decision date
- 2021-08-05
- Days to decision
- 230 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval of an adhesive change, minor manufacturing changes, and modification of a product specification.
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