BLAZER II XP, BLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS
FDA premarket approval P020025/S067 · decided 2015-04-06
Approval details
- PMA number
- P020025
- Supplement
- S067
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BLAZER II XP, BLAZER PRIME XP AND INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2015-01-13
- Decision date
- 2015-04-06
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A DESIGN CHANGE TO SYSTEM CABLES FROM LEAD CONTAININGSOLDER TO LEAD-FREE SOLDER.
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