|
Device | Maestro 4000 Controller Firmware |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P920047 |
Supplement Number | S117 |
Date Received | 08/09/2019 |
Decision Date | 08/23/2019 |
Product Code |
LPB |
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 Update Maestro 4000 Controller FW from version 5.14 to version 5.23 (market approved) in the field. |