|
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 | S080 |
Date Received | 11/13/2023 |
Decision Date | 12/12/2023 |
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 changes to the sterilization Chamber 9 Programmable Logic Controller at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility |