|
Device | BLAZER II CARDIAC ABLATION CATHETER AND STEEROCATH-T CARDIAC ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 4100 Hamline Avenue North St Paul, MN 55112 |
PMA Number | P920047 |
Supplement Number | S036 |
Date Received | 09/21/2006 |
Decision Date | 12/21/2006 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATION OF THE STEERING MECHANISM FOR THE N4 CURVE VERSION OF THE BLAZER II CARDIAC ABLATION CATHETER AND STEEROCATH-T CARDIAC ABLATION CATHETER AND THE USE OF A NEW SOLDERING FIXTURE IN THE MANUFACTURING PROCESS. |