|
Device | Blazer II XP Cardiac Ablation Catheter and Cable |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | BOSTON SCIENTIFIC 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P020025 |
Supplement Number | S122 |
Date Received | 10/10/2019 |
Decision Date | 11/07/2019 |
Product Code |
OAD |
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 Reduce the Ethylene Oxide gas concentration and qualify additional process challenge devices used in the BSC2000-2 sterilization cycle. |