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 | AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT) |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | DAVOL, INC., SUB. C.R. BARD, INC. |
| Date Received | 1974-05-17 |
| Decision Date | 1976-08-26 |
| PMA | N17600 |
| Supplement | S |
| Product Code | LMF |
| 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 | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAVOL, INC., SUB. C.R. BARD, INC. 100 Crossings Boulevard warwick, RI 02886 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| N17600 | | Original Filing |
| S035 |
2021-01-19 |
30-day Notice |
| S034 | | |
| S033 |
2020-02-28 |
30-day Notice |
| S032 |
2019-05-20 |
30-day Notice |
| S031 |
2018-12-03 |
30-day Notice |
| S030 |
2018-06-28 |
30-day Notice |
| S029 |
2014-05-30 |
30-day Notice |
| S028 |
2013-06-24 |
30-day Notice |
| S027 |
2013-05-28 |
30-day Notice |
| S026 |
2011-12-22 |
Special (immediate Track) |
| S025 |
2011-09-02 |
30-day Notice |
| S024 |
2009-03-20 |
30-day Notice |
| S023 |
2005-09-08 |
30-day Notice |
| S022 | | |
| S021 |
2004-10-04 |
30-day Notice |
| S020 |
2003-06-11 |
30-day Notice |
| S019 |
2001-10-18 |
Real-time Process |
| S018 |
2001-05-23 |
30-day Notice |
| S017 |
2000-12-14 |
Normal 180 Day Track |
| S016 |
1998-12-21 |
Real-time Process |
| S015 |
1998-07-21 |
30-day Notice |
| S014 |
1995-03-16 |
Normal 180 Day Track |
| S013 |
1995-01-23 |
Normal 180 Day Track |
| S012 |
1994-06-07 |
Normal 180 Day Track |
| S011 |
1993-08-23 |
Normal 180 Day Track |
| S010 |
1991-10-07 |
Normal 180 Day Track |
| S009 |
1986-09-16 |
Special (immediate Track) |
| S008 |
1983-08-26 |
|
| S007 |
1982-02-02 |
|
| S006 | | |
| S005 |
1981-08-20 |
|
| S004 |
1980-07-21 |
|
| S003 |
1980-07-08 |
|
| S002 |
1980-06-16 |
|
| S001 |
1980-01-28 |
|
NIH GUDID Devices