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 a gas pressure regulator adjustor screw change.
| Device | MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR |
| Classification Name | Ventilator, High Frequency |
| Generic Name | Ventilator, High Frequency |
| Applicant | Vyaire Medical Inc. |
| Date Received | 1997-01-03 |
| Decision Date | 1997-05-02 |
| PMA | P890057 |
| Supplement | S008 |
| Product Code | LSZ |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track |
| 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 |