|
Device | BLAZER OPEN-IRRIGATED ABLATION CATHETER |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P150005 |
Supplement Number | S007 |
Date Received | 04/15/2016 |
Decision Date | 06/23/2016 |
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 the addition of Lake Region Medical as an alternate vendor for the ring electrode component. |