|
Device | IntellaNav MiFi Open-Irrigated (OI) 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 | S076 |
Date Received | 04/18/2023 |
Decision Date | 07/17/2023 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for software modifications and relevant labeling changes for the RHYTHMIA HDx Mapping System software version v5.0.1. |