Approval for adding a “funnel” shape to the machine end of the lifeport adapter via the molding process. The disposable lifeport adapters were approved for use with the lifepulse high frequency ventilator model 204 in 1995.
| Device | LifePulse High Frequency Ventilator |
| Classification Name | Ventilator, High Frequency |
| Generic Name | Ventilator, High Frequency |
| Applicant | BUNNELL, INC. |
| Date Received | 2017-10-02 |
| Decision Date | 2017-12-20 |
| PMA | P850064 |
| Supplement | S035 |
| Product Code | LSZ |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Anesthesiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BUNNELL, INC. 436 Lawndale Dr. salt Lake City, UT 84115 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P850064 | | Original Filing |
| S047 |
2022-03-07 |
30-day Notice |
| S046 |
2021-05-27 |
30-day Notice |
| S045 | | |
| S044 |
2021-01-28 |
30-day Notice |
| S043 |
2020-10-29 |
30-day Notice |
| S042 |
2019-11-15 |
30-day Notice |
| S041 |
2019-10-24 |
30-day Notice |
| S040 | | |
| S039 |
2019-02-27 |
135 Review Track For 30-day Notice |
| S038 |
2018-10-25 |
30-day Notice |
| S037 |
2018-09-20 |
30-day Notice |
| S036 |
2018-01-29 |
Real-time Process |
| S035 |
2017-10-02 |
Real-time Process |
| S034 |
2017-06-07 |
30-day Notice |
| S033 |
2016-07-22 |
30-day Notice |
| S032 |
2016-05-24 |
Real-time Process |
| S031 |
2016-02-24 |
Real-time Process |
| S030 |
2015-03-31 |
Normal 180 Day Track |
| S029 |
2015-02-18 |
30-day Notice |
| S028 |
2015-02-04 |
Normal 180 Day Track |
| S027 |
2014-08-25 |
Normal 180 Day Track No User Fee |
| S026 |
2014-01-27 |
30-day Notice |
| S025 |
2013-09-09 |
30-day Notice |
| S024 | | |
| S023 |
2013-06-10 |
Normal 180 Day Track |
| S022 | | |
| S021 |
2012-09-07 |
Normal 180 Day Track |
| S020 | | |
| S019 | | |
| S018 |
2010-02-22 |
Normal 180 Day Track |
| S017 |
2001-04-04 |
Normal 180 Day Track |
| S016 |
1999-09-10 |
Special (immediate Track) |
| S015 |
1998-10-21 |
Normal 180 Day Track |
| S014 |
1998-08-28 |
Special (immediate Track) |
| S013 | | |
| S012 |
1997-04-11 |
Special (immediate Track) |
| S011 |
1995-04-05 |
Normal 180 Day Track |
| S010 |
1994-08-05 |
Normal 180 Day Track |
| S009 |
1992-11-27 |
Normal 180 Day Track |
| S008 | | |
| S007 | | |
| S006 |
1991-08-01 |
Normal 180 Day Track |
| S005 |
1990-10-01 |
Normal 180 Day Track |
| S004 | | |
| S003 |
1989-07-24 |
Normal 180 Day Track |
| S002 |
1989-02-09 |
Normal 180 Day Track |
| S001 |
1988-09-19 |
Normal 180 Day Track |
NIH GUDID Devices