|
Device | Blazer Open-Irrigated Ablation Catheter and IntellaNav 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 | S058 |
Date Received | 09/29/2020 |
Decision Date | 12/18/2020 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the design and associated manufacturing changes to the Blazer OI and IntellaNav OI ablation catheters to standardize the design and manufacture of these catheters with other BSC OI catheters. |