EPT-1000 XP CARDIAC ABLATION SYSTEM
FDA premarket approval P020025/S001 · decided 2004-02-23
Approval details
- PMA number
- P020025
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- 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
- 2003-09-24
- Decision date
- 2004-02-23
- Days to decision
- 152 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE BLAZER XP RPM CATHETER WHICH COMBINES THE FEATURES OF THE BLAZER II XP WITH THE REAL TIME POSITION MANAGEMENT (RPM) TRACKING SYSTEM TECHNOLOGY APPROVED FOR THE CHILLI RPM CATHETER.
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