Modification to the glutaraldehyde processing solutions used for valve manufacturing.
| Device | Hancock Modified Orifice Valved Conduit |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | MEDTRONIC HEART VALVES |
| Date Received | 2018-06-21 |
| Decision Date | 2018-06-29 |
| PMA | P790007 |
| Supplement | S057 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC HEART VALVES 1851 East Deere Ave. santa Ana, CA 92705 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P790007 | | Original Filing |
| S064 |
2020-11-19 |
30-day Notice |
| S063 | | |
| S062 |
2019-09-26 |
Real-time Process |
| S061 |
2019-06-20 |
30-day Notice |
| S060 |
2019-01-29 |
30-day Notice |
| S059 | | |
| S058 |
2018-10-01 |
30-day Notice |
| S057 |
2018-06-21 |
30-day Notice |
| S056 |
2018-04-12 |
30-day Notice |
| S055 |
2017-12-20 |
30-day Notice |
| S054 | | |
| S053 |
2017-09-11 |
30-day Notice |
| S052 |
2017-08-14 |
135 Review Track For 30-day Notice |
| S051 |
2017-07-10 |
30-day Notice |
| S050 |
2017-02-08 |
30-day Notice |
| S049 |
2016-10-25 |
30-day Notice |
| S048 |
2016-05-06 |
30-day Notice |
| S047 |
2016-01-29 |
Real-time Process |
| S046 |
2015-10-13 |
30-day Notice |
| S045 |
2014-11-07 |
30-day Notice |
| S044 |
2014-10-14 |
30-day Notice |
| S043 |
2014-08-05 |
30-day Notice |
| S042 |
2014-06-23 |
30-day Notice |
| S041 |
2014-04-23 |
30-day Notice |
| S040 |
2013-10-25 |
Real-time Process |
| S039 |
2013-07-01 |
30-day Notice |
| S038 |
2013-04-02 |
135 Review Track For 30-day Notice |
| S037 |
2013-04-01 |
135 Review Track For 30-day Notice |
| S036 |
2013-04-01 |
30-day Notice |
| S035 |
2013-02-13 |
30-day Notice |
| S034 |
2012-12-13 |
30-day Notice |
| S033 |
2012-11-19 |
30-day Notice |
| S032 |
2012-03-23 |
Normal 180 Day Track |
| S031 |
2011-08-17 |
30-day Notice |
| S030 |
2011-07-28 |
30-day Notice |
| S029 | | |
| S028 |
2010-10-21 |
30-day Notice |
| S027 |
2010-10-20 |
30-day Notice |
| S026 |
2010-06-18 |
30-day Notice |
| S025 |
2010-04-30 |
30-day Notice |
| S024 |
2010-01-06 |
135 Review Track For 30-day Notice |
| S023 |
2009-10-05 |
30-day Notice |
| S022 |
2009-07-09 |
30-day Notice |
| S021 |
2007-10-15 |
30-day Notice |
| S020 |
2007-09-19 |
30-day Notice |
| S019 | | |
| S018 |
2007-04-13 |
30-day Notice |
| S017 |
2005-12-27 |
135 Review Track For 30-day Notice |
| S016 |
1999-08-31 |
Normal 180 Day Track |
| S015 |
1998-05-12 |
Normal 180 Day Track |
| S014 |
1998-04-06 |
Normal 180 Day Track |
| S013 |
1996-05-13 |
Normal 180 Day Track |
| S012 |
1993-04-12 |
Normal 180 Day Track |
| S011 |
1992-12-18 |
Normal 180 Day Track |
| S010 |
1992-07-20 |
Normal 180 Day Track |
| S009 |
1989-07-26 |
Normal 180 Day Track |
| S008 | | |
| S007 |
1985-02-08 |
|
| S006 | | |
| S005 |
1981-05-04 |
|
| S004 |
1980-10-06 |
|
| S003 |
1979-12-27 |
|
| S002 |
1979-12-27 |
|
| S001 |
1979-12-27 |
|
NIH GUDID Devices