EPT-1000 XP CARDIAC ABLATION SYSTEM
FDA premarket approval P020025/S010 · decided 2005-02-28
Approval details
- PMA number
- P020025
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EPT-1000 XP CARDIAC ABLATION SYSTEM
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2005-01-24
- Decision date
- 2005-02-28
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE BLAZER II AND BLAZER II XP CATHETERS WITH MODIFIED STEERING WIRE SUBASSEMBLIES.
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