This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the modification of the breathing circuit to include two filters, one in the inspiratory limb after the gas supply line and relieve valve and another at the expiratory limb before the dump valve.
| Device | MODEL 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR |
| Classification Name | Ventilator, High Frequency |
| Generic Name | Ventilator, High Frequency |
| Applicant | Vyaire Medical Inc. |
| Date Received | 2007-01-03 |
| Decision Date | 2007-04-25 |
| PMA | P890057 |
| Supplement | S019 |
| Product Code | LSZ |
| Advisory Committee | Anesthesiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Vyaire Medical Inc. 26125 Riverwoods Blvd mettawa, IL 60045 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890057 | Original Filing | |
| S025 | 2022-04-25 | Real-time Process |
| S024 | ||
| S023 | ||
| S022 | 2014-04-29 | 30-day Notice |
| S021 | 2013-10-28 | 30-day Notice |
| S020 | 2011-12-01 | 135 Review Track For 30-day Notice |
| S019 | 2007-01-03 | Real-time Process |
| S018 | 2004-12-20 | Real-time Process |
| S017 | 2004-07-14 | Normal 180 Day Track No User Fee |
| S016 | ||
| S015 | 2001-08-09 | Normal 180 Day Track |
| S014 | 2001-02-22 | Panel Track |
| S013 | 1999-11-19 | Normal 180 Day Track |
| S012 | ||
| S011 | ||
| S010 | 1997-07-03 | Normal 180 Day Track |
| S009 | 1997-05-16 | Normal 180 Day Track |
| S008 | 1997-01-03 | Normal 180 Day Track |
| S007 | 1996-02-26 | Normal 180 Day Track |
| S006 | ||
| S005 | 1993-03-15 | Normal 180 Day Track |
| S004 | 1993-02-09 | Normal 180 Day Track |
| S003 | 1992-06-29 | Panel Track |
| S002 | 1992-02-03 | Normal 180 Day Track |
| S001 | 1991-04-04 | Normal 180 Day Track |