Blazer IITM XP Cardiac RF Ablation System (also branded as Blazer II Prime XP, IntellaTip MiFi XP, IntellaTip MiFi OI, I
FDA premarket approval P020025/S138 · decided 2023-04-27
Approval details
- PMA number
- P020025
- Supplement
- S138
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Blazer IITM XP Cardiac RF Ablation System (also branded as Blazer II Prime XP, IntellaTip MiFi XP, IntellaTip MiFi OI, I
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2023-03-30
- Decision date
- 2023-04-27
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Use of parametric release and an alternate process challenge device for the BSC2019 ethylene oxide sterilization cycle at the Steris AST Costa Rica Facility.
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