|
Device | IntellaNav MiFi Open-Irrigated (OI) and IntellaTip MiFi OI ablation catheters |
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 | S056 |
Date Received | 05/21/2020 |
Decision Date | 06/04/2020 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Add an alternate supplier (RMS) for the proximal insert component used in manufacturing of the ablation catheters. |