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Device | 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator |
Generic Name | VENTILATOR, HIGH FREQUENCY |
Applicant | Vyaire Medical Inc. 26125 Riverwoods Blvd Mettawa, IL 60045 |
PMA Number | P890057 |
Supplement Number | S028 |
Date Received | 07/03/2023 |
Decision Date | 02/20/2024 |
Product Code |
LSZ |
Advisory Committee |
Anesthesiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the new manufacturing location for the 3100 patient circuits tubing, 77273-101 and 772722-102. |