The lifepulse high frequency ventilator is indicated for use in ventilating critically ill infants with pulmonary interstitial emphysema (pie). Infants studied ranged in birth weight from 750 to 3,529 grams and in gestational age from 24 to 41 weeks. The lifepulse high frequency ventilator is also indicated for use in ventilating critically illinfants with respiratory distress syndrome (rds) complicated by pulmonary air leaks who are, in the opinion of their physicians, failing on conventional ventilation. The infantsstudied ranged in birth weight from 600 to 3,660 grams and in gestational age from 24 to 38 weeks.
| Device | Model 203 Life Pulse High Frequency Ventilator |
| Classification Name | Ventilator, High Frequency |
| Generic Name | Ventilator, High Frequency |
| Applicant | BUNNELL, INC. |
| Date Received | 2018-09-20 |
| Decision Date | 2018-10-19 |
| PMA | P850064 |
| Supplement | S037 |
| 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 | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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