This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the selute steroid eluting endocardial lead models 4185 and 4285
| Device | SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285 |
| Generic Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 1995-01-13 |
| Decision Date | 1996-05-08 |
| Notice Date | 1996-10-24 |
| PMA | P950001 |
| Supplement | S |
| Product Code | NVN |
| Docket Number | 96M-0371 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950001 | Original Filing | |
| S029 | 2021-03-08 | 30-day Notice |
| S028 | 2016-05-27 | 30-day Notice |
| S027 | 2014-06-30 | 30-day Notice |
| S026 | 2013-08-29 | 30-day Notice |
| S025 | 2012-11-08 | 30-day Notice |
| S024 | 2012-10-02 | 30-day Notice |
| S023 | 2012-03-26 | 30-day Notice |
| S022 | 2011-04-01 | 30-day Notice |
| S021 | 2009-12-18 | 30-day Notice |
| S020 | 2009-12-16 | 30-day Notice |
| S019 | ||
| S018 | ||
| S017 | 2006-04-13 | 30-day Notice |
| S016 | 2006-04-13 | 30-day Notice |
| S015 | 2005-10-06 | Real-time Process |
| S014 | 2005-02-24 | 30-day Notice |
| S013 | 2004-12-03 | 30-day Notice |
| S012 | 2004-10-21 | 30-day Notice |
| S011 | 2004-04-14 | 30-day Notice |
| S010 | 2004-01-13 | 30-day Notice |
| S009 | 2002-11-13 | 30-day Notice |
| S008 | 2000-08-21 | Normal 180 Day Track |
| S007 | 2000-05-31 | Real-time Process |
| S006 | 2000-04-17 | Real-time Process |
| S005 | 1999-12-16 | Normal 180 Day Track |
| S004 | 1999-11-15 | Normal 180 Day Track |
| S003 | 1997-10-01 | Normal 180 Day Track |
| S002 | 1997-04-03 | Normal 180 Day Track |
| S001 | 1996-10-16 | Normal 180 Day Track |