|
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 | S111 |
Date Received | 04/06/2018 |
Decision Date | 09/07/2018 |
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 updating the optimized BSC2000-2 cycle conducted in Chamber 7 at the BSC Coventry, RI facility with new Programmable Logic Controller (PLC) software. |