|
Device | BLAZER II XP CARDIAC ABLATION CATHETER & CABLE/BLAZER PRIME XP CARDIAC ABLATION CATHETER |
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 | S025 |
Date Received | 10/07/2010 |
Decision Date | 03/31/2011 |
Product Code |
OAD |
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. |