|
Device | EPT-1000 XP CARDIAC ABLATION SYSTEM |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St Paul, MN 55112 |
PMA Number | P020025 |
Supplement Number | S001 |
Date Received | 09/24/2003 |
Decision Date | 02/23/2004 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
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. |