|
Device | BLAZER II AND BLAZER II XP CARDIAC ABLATION CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S026 |
Date Received | 01/24/2005 |
Decision Date | 02/28/2005 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE BLAZER II AND BLAZER II XP CATHETERS WITH MODIFIED STEERING WIRE SUBASSEMBLIES. |