|
Device | Blazer II, Blazer II HTD, Blazer Prime HTD |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S091 |
Date Received | 04/15/2016 |
Decision Date | 06/23/2016 |
Product Code |
LPB |
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 ring electrode part numbers 150493, 14295-001, and 90414197-01. |