EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM
FDA premarket approval P020025 · decided 2003-08-25
Approval details
- PMA number
- P020025
- Trade name
- EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific
- Date received
- 2002-06-24
- Decision date
- 2003-08-25
- Days to decision
- 427 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM. THE BLAZER II XP CARDIAC ABLATION CATHETER IS INDICATED FOR USE WITH THE EPT-1000 XP CARDIAC ABLATION CONTROLLER AND ACCESSORIES FOR THE TREATMENT OF SUSTAINED OR RECURRENT TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER. THE EPT-1000 XP CARDIAC ABLATION CONTROLLER AND ACCESSORIES ARE INDICATED FOR USE IN CONJUNCTION WITH STANDARD AND HIGH POWER CATHETERS FOR CARDIAC ABLATION PROCEDURES.
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