|
Device | Blazer IITM Cardiac Ablation Catheter and Cable |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S099 |
Date Received | 06/26/2017 |
Decision Date | 07/24/2017 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Optimized BSC2000-2 EO sterilization cycle in Chambers 8 and 9 at Synergy Health Tullamore. |