|
Device | BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 4100 Hamline Avenue North St Paul, MN 55112 |
PMA Number | P920047 |
Supplement Number | S044 |
Date Received | 10/07/2010 |
Decision Date | 03/31/2011 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE STERILIZATION EQUIPMENT. |