EPT-1000 XP CARDIAC ABLATION SYSTEM
FDA premarket approval P020025/S006 · decided 2004-07-27
Approval details
- PMA number
- P020025
- Supplement
- S006
- 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
- 2004-05-26
- Decision date
- 2004-07-27
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ELIMINATION OF EXCESS WIRING IN THE SUBASSEMBLY OF EPT-1000 XP CATHETERS.
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