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 radiation-emitting products vaccines, blood & biologics animal & veterinary cosmetics tobacco products premarket approval (pma) var mp = { version: '1. 0. 22', domains: {'es':'esp. Fda. Gov'}, srclang: 'en', urllang: 'mp_js_current_lang', srcurl: unescape('mp_js_orgin_url'), init: function(){ if (mp. Urllang. Indexof('p_js_')==1) { mp. Srcurl=window. Top. Document. Location. Href; mp. Urllang=mp. Srclang; } }, getcookie: function(name){ var start=document. Cookie. Indexof(name+'='); if(start < 0) return null; start=start+name. Length+1; var end=document. Cookie. Indexof(';', start); if(end < 0) end=document. Cookie. Length; while (document. Cookie. Charat(start)==' '){ start++; } return unescape(document. Cookie. Substring(start,end)); }, setcookie: function(name,value,path,domain){ var cookie=name+'='+escape(value); if(path)cookie+='; path='+path; if(domain)cookie+='; domain='+domain; var now=new date(); now. Settime(now. Gettime()+1000*60*60*24*365); cookie+='; expires='+now. Toutcstring(); document. Cookie=cookie; }, switchlanguage: function(lang){ if(lang! =mp. Srclang){ var script=document. Createelement('script'); script. Src=location. Protocol+'//'+mp. Domains[lang]+'/'+mp. Srclang+lang+'/? 1023749632;'+encodeuricomponent(mp. Srcurl); document. Body. Appendchild(script); } else if(lang==mp. Srclang && mp. Urllang! =mp. Srclang){ var script=document. Createelement('script'); script. Src=location. Protocol+'//'+mp. Domains[mp. Urllang]+'/'+mp. Srclang+mp. Urllang+'/? 1023749634;'+encodeuricomponent(location. Href); document. Body. Appendchild(script); } return false; }, switchtolang: function(url) { window. Top. Location. Href=url; } }; var addthis_config = {data_track_clickback: true, ui_508_compliant: true, services_compact: 'facebook, twitter, linkedin, pinterest_share, email', services_exclude: 'print', image_container: "#user_provided" } ; fda home medical devices databases -. Pma { color: #000000; width: 900px; float: right; margin: 0px 25px 0px 0px; }. Pma-left { color: #000000; float: left; width: 610px; margin: 9px 30px 0px 0; }. Pma-right { color: #000000; float: right; width: 190px; margin: 9px 18px 0 0; padding: 8px 12px 10px 12px; background-color: #f3f3f3; border: 1px solid #b0b0b0; border-radius: 6px; }. Pma-intro { margin: 0 0 18px 0; padding: 5px 12px 12px 12px; background-color: #e8eff5; border: 1px solid #b0b0b0; border-radius: 6px; } #pma-form { table-layout:fixed; width: 610px; font-size: 11px; border: 1px solid #b0b0b0; } #pma-form-title{ padding: 6px 6px 6px 6px; width: 100%; background-color: #e8eff5; border-bottom: 1px solid #b0b0b0; margin-top: 0px; } #pma-form-title-left { font-size: 13px; font-weight: bold; } #pma-form-title-right { font-size: 11px; padding: 0px 0px 0px 300px; } #pma-results-table { table-layout:fixed; width: 610px; border-color: #b0b0b0; border-width: 0 0 1px 1px; border-style: solid; } #pma-results-table th { padding: 6px 12px; background-color: #e8eff5; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; font-size: 12px; } #pma-results-table td { padding: 6px 12px; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; text-transform: capitalize; } #pma-results-table tr:nth-child(odd) { background-color: #f3f3f3; }. Sort { float: right; margin-top: 5px;}. Sort a { color: #484138; }. Sort a:hover { color: #0f2a8c; }
| Device | MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR |
| Classification Name | Ventilator, High Frequency |
| Generic Name | Ventilator, High Frequency |
| Applicant | BUNNELL, INC. |
| Date Received | 1985-09-04 |
| Decision Date | 1988-06-30 |
| Notice Date | 1988-08-10 |
| PMA | P850064 |
| Supplement | S |
| Product Code | LSZ |
| Docket Number | 88M-0263 |
| Advisory Committee | Anesthesiology |
| 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