PMA P020025S001
- Device
- EPT-1000 XP CARDIAC ABLATION SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S001
- Product code
- OAD
- Decision date
- 2004-02-23
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order 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.
Current openFDA PMA Record#
- Device
- EPT-1000 XP CARDIAC ABLATION SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S001
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2004-02-23
- Decision code
- APPR
- Date received
- 2003-09-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.