Approval for a manufacturing site lcoated at medtronic puerto rico, inc. , (mpri), road 149, rm. 56. 3, villalba, puerto rico 00755.
| Device | MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 |
| Classification Name | Permanent Pacemaker Electrode |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | MEDTRONIC Inc. |
| Date Received | 1998-04-20 |
| Decision Date | 1998-08-12 |
| PMA | P950024 |
| Supplement | S001 |
| Product Code | DTB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P950024 | | Original Filing |
| S105 |
2022-11-16 |
30-day Notice |
| S104 |
2022-05-20 |
30-day Notice |
| S103 |
2022-04-14 |
30-day Notice |
| S102 |
2022-01-13 |
30-day Notice |
| S101 |
2021-11-18 |
30-day Notice |
| S100 |
2021-10-05 |
30-day Notice |
| S099 |
2021-08-09 |
30-day Notice |
| S098 |
2021-02-05 |
30-day Notice |
| S097 |
2020-12-01 |
30-day Notice |
| S096 | | |
| S095 |
2020-10-23 |
30-day Notice |
| S094 |
2020-07-09 |
30-day Notice |
| S093 |
2020-06-26 |
30-day Notice |
| S092 |
2020-03-23 |
Real-time Process |
| S091 |
2020-02-20 |
30-day Notice |
| S090 |
2019-11-18 |
30-day Notice |
| S089 | | |
| S088 |
2019-09-16 |
30-day Notice |
| S087 |
2019-07-01 |
30-day Notice |
| S086 |
2019-06-21 |
30-day Notice |
| S085 |
2019-06-10 |
30-day Notice |
| S084 |
2019-02-28 |
30-day Notice |
| S083 |
2018-11-21 |
30-day Notice |
| S082 |
2018-10-23 |
30-day Notice |
| S081 |
2018-10-18 |
30-day Notice |
| S080 |
2018-09-26 |
30-day Notice |
| S079 |
2018-05-15 |
30-day Notice |
| S078 |
2018-02-22 |
30-day Notice |
| S077 |
2017-11-20 |
30-day Notice |
| S076 |
2017-10-20 |
30-day Notice |
| S075 |
2017-08-07 |
30-day Notice |
| S074 |
2017-06-28 |
30-day Notice |
| S073 |
2017-06-07 |
30-day Notice |
| S072 |
2017-01-17 |
30-day Notice |
| S071 |
2016-11-28 |
30-day Notice |
| S070 |
2016-11-14 |
30-day Notice |
| S069 |
2016-10-05 |
30-day Notice |
| S068 |
2016-06-24 |
30-day Notice |
| S067 |
2015-12-28 |
30-day Notice |
| S066 |
2015-12-22 |
30-day Notice |
| S065 |
2015-09-10 |
30-day Notice |
| S064 |
2015-04-17 |
30-day Notice |
| S063 |
2014-08-27 |
30-day Notice |
| S062 |
2014-08-13 |
30-day Notice |
| S061 |
2014-07-24 |
30-day Notice |
| S060 |
2014-07-14 |
30-day Notice |
| S059 |
2014-02-27 |
30-day Notice |
| S058 |
2014-01-29 |
30-day Notice |
| S057 |
2013-12-24 |
30-day Notice |
| S056 |
2013-12-19 |
30-day Notice |
| S055 |
2013-11-27 |
30-day Notice |
| S054 |
2013-10-30 |
30-day Notice |
| S053 |
2013-10-24 |
30-day Notice |
| S052 |
2013-09-30 |
30-day Notice |
| S051 |
2013-09-17 |
30-day Notice |
| S050 |
2013-05-17 |
Real-time Process |
| S049 |
2013-04-30 |
30-day Notice |
| S048 |
2013-04-10 |
Normal 180 Day Track No User Fee |
| S047 |
2013-03-22 |
30-day Notice |
| S046 |
2012-11-21 |
30-day Notice |
| S045 |
2012-09-28 |
30-day Notice |
| S044 |
2012-09-14 |
Normal 180 Day Track No User Fee |
| S043 |
2012-09-04 |
30-day Notice |
| S042 |
2012-08-03 |
30-day Notice |
| S041 |
2012-02-29 |
30-day Notice |
| S040 |
2011-12-09 |
Normal 180 Day Track No User Fee |
| S039 |
2011-11-25 |
30-day Notice |
| S038 |
2011-11-21 |
Normal 180 Day Track |
| S037 |
2011-10-24 |
135 Review Track For 30-day Notice |
| S036 |
2011-08-17 |
30-day Notice |
| S035 |
2011-07-18 |
30-day Notice |
| S034 |
2011-07-08 |
30-day Notice |
| S033 |
2011-06-28 |
30-day Notice |
| S032 |
2011-06-08 |
30-day Notice |
| S031 |
2011-04-26 |
30-day Notice |
| S030 |
2011-04-12 |
30-day Notice |
| S029 |
2011-03-22 |
135 Review Track For 30-day Notice |
| S028 |
2011-02-28 |
30-day Notice |
| S027 |
2010-11-12 |
30-day Notice |
| S026 |
2010-10-26 |
30-day Notice |
| S025 | | |
| S024 |
2010-07-15 |
30-day Notice |
| S023 |
2010-07-15 |
30-day Notice |
| S022 |
2010-07-15 |
30-day Notice |
| S021 |
2010-06-28 |
135 Review Track For 30-day Notice |
| S020 |
2010-03-29 |
30-day Notice |
| S019 |
2010-01-19 |
30-day Notice |
| S018 |
2010-01-15 |
Real-time Process |
| S017 |
2009-02-25 |
Normal 180 Day Track No User Fee |
| S016 |
2009-02-05 |
30-day Notice |
| S015 |
2008-12-11 |
30-day Notice |
| S014 | | |
| S013 |
2008-11-03 |
30-day Notice |
| S012 | | |
| S011 |
2008-06-17 |
30-day Notice |
| S010 |
2008-04-14 |
30-day Notice |
| S009 |
2008-03-10 |
135 Review Track For 30-day Notice |
| S008 |
2006-05-10 |
135 Review Track For 30-day Notice |
| S007 |
2005-12-30 |
Normal 180 Day Track No User Fee |
| S006 |
2002-12-24 |
Real-time Process |
| S005 |
2001-11-05 |
Special (immediate Track) |
| S004 |
2001-07-17 |
30-day Notice |
| S003 |
1998-07-27 |
Normal 180 Day Track |
| S002 |
1998-07-01 |
Normal 180 Day Track |
| S001 |
1998-04-20 |
Normal 180 Day Track |
NIH GUDID Devices