LIFE PULSE HIGH FREQUENCY JET VENTILATOR

Ventilator, High Frequency

FDA Premarket Approval P850064 S009

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.

Pre-market Approval Supplement Details

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; }

DeviceLIFE PULSE HIGH FREQUENCY JET VENTILATOR
Classification NameVentilator, High Frequency
Generic NameVentilator, High Frequency
ApplicantBUNNELL, INC.
Date Received1992-11-27
Decision Date1993-04-02
PMAP850064
SupplementS009
Product CodeLSZ
Docket NumberPremarket 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 CommitteeAnesthesiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address BUNNELL, INC. 436 Lawndale Dr. salt Lake City, UT 84115

Supplemental Filings

Supplement NumberDateSupplement Type
P850064Original 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

Device IDPMASupp
10616120000089 P850064 000
00616120000020 P850064 000
00616120000006 P850064 000
00616120000013 P850064 017
00616120000112 P850064 028
00616120000105 P850064 028

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