EPT-1000 XP CARDIAC ABLATION SYSTEM
FDA premarket approval P020025/S004 · decided 2004-06-09
Approval details
- PMA number
- P020025
- Supplement
- S004
- 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
- 2003-12-18
- Decision date
- 2004-06-09
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A CHANGE IN DESIGN OF THE EPT-1000 XP CARDIAC ABLATION CONTROLLER. THE CHANGE IN DESIGN INCORPORATES THE ORIGINALLY APPROVED EPT-1000 XP CONTROLLER WITH TRACK WHILE ABLATE (TWA) TECHNOLOGY TO VISUALIZE CATHETER NAVIGATION DURING RF ENERGY DELIVERY USING THE REAL TIME POSITION MANAGEMENT (RPM) SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TRACK WHILE ABLATE (TWA) EPT-1000 XP CARDIAC ABLATION SYSTEM. THE TWA EPT-1000 XP CARDIAC ABLATION CONTROLLER AND ACCESSOR
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.