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.
Approval to extend the shelf life of the drug plug component of the leads from one year to three years. The shelf life of the finished leads remains two years.
| Device | SELUTE AND SELUTE PICOTIP |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 2005-10-06 |
| Decision Date | 2005-11-15 |
| PMA | P950001 |
| Supplement | S015 |
| Product Code | DTB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |