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 model 3100b hfov. The device is indicated for use in the ventilatory support and treatment of selected patients 35 kilograms and greater with acute respiratory failure.
| Device | MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV) |
| Classification Name | Ventilator, High Frequency |
| Generic Name | Ventilator, High Frequency |
| Applicant | Vyaire Medical Inc. |
| Date Received | 2001-02-22 |
| Decision Date | 2001-09-24 |
| Notice Date | 2001-11-19 |
| PMA | P890057 |
| Supplement | S014 |
| Product Code | LSZ |
| Docket Number | 01M-0520 |
| Advisory Committee | Anesthesiology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Vyaire Medical Inc. 26125 Riverwoods Blvd mettawa, IL 60045 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |