|
Device | BLAZER II XP AND BLAZER XP RPM CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 4100 Hamline Avenue North St Paul, MN 55112 |
PMA Number | P920047 |
Supplement Number | S024 |
Date Received | 05/26/2004 |
Decision Date | 07/27/2004 |
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 ELIMINATION OF EXCESS WIRING IN THE SUBASSEMBLY OF THE BLAZER II XP AND BLAZER XP RPM CATHETERS. |