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.
Change in the bioburden sampling frequency in the clonmel and st paul facilities for the devices.
| Device | SELUTE LEAD SYSTEM |
| Generic Name | Permanent Defibrillator Electrodes |
| Applicant | BOSTON SCIENTIFIC |
| Date Received | 2014-06-30 |
| Decision Date | 2014-07-30 |
| PMA | P950001 |
| Supplement | S027 |
| Product Code | NVY |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |