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 for: a) selute(r) picotip(tm) steroid eluting, endocardial pacing lead model 4030, 4031, 4032, 4033, 4034, and 4035 which are indicated for chronic pacing and asensing of the ventricle when used with a compatible pulse generator, and b) the use of the cosmed of illinois facility as an alternate sterilization site.
| Device | SELUTE PICOTIP STEROID ELUTING LEAD |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 1997-10-01 |
| Decision Date | 1998-04-08 |
| PMA | P950001 |
| Supplement | S003 |
| Product Code | DTB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| 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 |